Generated by All in One SEO v5.0.1.1, this is an llms.txt file, used by LLMs to index the site. # The Tao of Excellence Specialist consultants for the medical devices industry ## Sitemaps - [XML Sitemap](https://taoexcellence.ch/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [MRA & MDR: Find the right solutions for your business](https://taoexcellence.ch/mra-mdr-find-the-right-solutions-for-your-business/) - 9 March 2020 Join us for a specialist webinar for Swiss medtech manufacturers. This event is designed to help Swiss manufacturers navigate the current uncertainty in the medical devices market between Switzerland and the EU. - [MRA & MDR: Find the right solutions for your business](https://taoexcellence.ch/mra-mdr-find-the-right-solutions-for-your-business-2/) - 19 March 2020 Join us for a specialist webinar for Swiss medtech manufacturers. This event is designed to help Swiss manufacturers navigate the current uncertainty in the medical devices market between Switzerland and the EU. - [Process Improvement - QMS+ course with activities for children.](https://taoexcellence.ch/six-sigma-yellow-belt/) - 14–17 April A process improvement course based on Six Sigma and designed for people working in the medical device and pharmaceutical industries. - [Process Improvement - QMS+ course with activities for children.](https://taoexcellence.ch/six-sigma-yellow-belt-2/) - 11–14 May A process improvement course based on Six Sigma and designed for people working in the medical device and pharmaceutical industries. - [Prozessverbesserung - QMS+ Kurs mit Aktivitäten für Kinder.](https://taoexcellence.ch/six-sigma-yellow-belt-2/) - 11–14 May Dieser Kurs rund um das Thema Prozessverbesserung orientiert sich am Six Sigma Ansatz und richtet sich an Personen, die in der Medizintechnik-und Pharmaindustrie tätig sind. - [Prozessverbesserung - QMS+ Kurs mit Aktivitäten für Kinder.](https://taoexcellence.ch/six-sigma-yellow-belt/) - 14–17 April Dieser Kurs rund um das Thema Prozessverbesserung orientiert sich am Six Sigma Ansatz und richtet sich an Personen, die in der Medizintechnik-und Pharmaindustrie tätig sind. - [MRA & MDR: Find the right solutions for your business](https://taoexcellence.ch/mra-mdr-find-the-right-solutions-for-your-business-2/) - 19 März 2020 Nehmen Sie an diesem speziellen Webinar für Schweizer medtech-Hersteller. Diese Veranstaltung soll Schweizer Herstellern helfen, die aktuelle Unsicherheit auf dem Markt für medizinische Geräte zwischen der Schweiz und der EU zu bewältigen. - [MRA & MDR: Find the right solutions for your business](https://taoexcellence.ch/mra-mdr-find-the-right-solutions-for-your-business/) - 9 März 2020 Nehmen Sie an diesem speziellen Webinar für Schweizer medtech-Hersteller. Diese Veranstaltung soll Schweizer Herstellern helfen, die aktuelle Unsicherheit auf dem Markt für medizinische Geräte zwischen der Schweiz und der EU zu bewältigen. - [Bridging the gap in MDR implementation](https://taoexcellence.ch/bridging-the-gap-in-mdr-implementation/) - Quality Implementation Manager Deepa Rajagopalan talks to Henrietta Shirley about MDR implementation and bridging the gap between regulation and innovation in medtech. - [Bridging the gap in MDR implementation](https://taoexcellence.ch/bridging-the-gap-in-mdr-implementation/) - Quality Implementation Manager Deepa Rajagopalan talks to Henrietta Shirley about MDR implementation and bridging the gap between regulation and innovation in medtech. - [Absent MRA, immanent MDR: Actions for Swiss medtech](https://taoexcellence.ch/absent-mra-immanent-mdr-actions-for-swiss-medtech/) - The situation around the bilateral agreements and the MRA (Mutual Recognition Agreement) between the EU and Switzerland is getting worse. - [Fehlendes MRA und MDR](https://taoexcellence.ch/absent-mra-immanent-mdr-actions-for-swiss-medtech/) - Die Situation rund um die Bilateralen Abkommen und das MRA (Mutual recognition agreement) zwischen EU und der Schweiz schärft sich weiter zu. - [How does regulation affect innovation?](https://taoexcellence.ch/how-does-regulation-affect-innovation/) - The human mind is curious. It is our inquisitiveness that has led to some of humanity’s greatest discoveries. From fire to the apple that first sparked Newton’s theory of gravity, our curiosity has taken us to the moon... - [How does regulation affect innovation?](https://taoexcellence.ch/how-does-regulation-affect-innovation/) - The human mind is curious. It is our inquisitiveness that has led to some of humanity’s greatest discoveries. From fire to the apple that first sparked Newton’s theory of gravity, our curiosity has taken us to the moon... - [Tactical Session: working with a Notified Body](https://taoexcellence.ch/tactical-session-working-with-a-notified-body/) - Date: 10th October 2019 Time: 4.30 – 9pm Location: ITS industrial and techno centre, Schaffhausen This event is free and has 40 places. Please contact us for more information or to reserve a seat. - [Tactical Session: working with a Notified Body](https://taoexcellence.ch/tactical-session-working-with-a-notified-body/) - Date: 10th October 2019 Time: 4.30 – 9pm Location: ITS industrial and techno centre, Schaffhausen This event is free and has 40 places. Please contact us for more information or to reserve a seat. - [Six Sigma Yellow Belt Kurs: Medizintechnik](https://taoexcellence.ch/six-sigma-yellow-belt-kurs-medizintechnik/) - Datum: 21–22 November 2019 (2 Tage) Ort: Luzern Dieser Kurs richtet sich an Mitarbeiter der Fachabteilungen speziell in der Medizintechnik. Die Teilnehmer lernen die Six Sigma Methodik kennen. - [Regulatory strategies for the MDR](https://taoexcellence.ch/regulatory-strategies-for-the-mdr/) - Following the intensive workshop (Tactical Session) we recently presented in Schaffhausen—and reported in the Schaffhauser Nachrichten—we have selected a series of articles that shed light on the MDR process. - [Artikelauswahl für die MDR](https://taoexcellence.ch/regulatory-strategies-for-the-mdr/) - Dieses Material enthält die wichtigsten Schritte, welche für MDR-betroffene Unternehmen jetzt interessant sind. Jeder Artikel ist kurz zusammengefasst und durch Anklicken direkt zugänglich. - [Six Sigma Yellow Belt Kurs: Medizintechnik](https://taoexcellence.ch/six-sigma-yellow-belt-kurs-medizintechnik/) - Datum: 21–22 November 2019 (2 Tage) Ort: Luzern Dieser Kurs richtet sich an Mitarbeiter der Fachabteilungen speziell in der Medizintechnik. Die Teilnehmer lernen die Six Sigma Methodik kennen. - [Accessing funding and reimbursement in medtech](https://taoexcellence.ch/accessing-funding-and-reimbursement-in-medtech/) - Funding and reimbursement systems pay for medical devices. However, accessing these systems effectively and efficiently is often far from clear to manufacturers. - [Accessing funding and reimbursement in medtech](https://taoexcellence.ch/accessing-funding-and-reimbursement-in-medtech/) - Funding and reimbursement systems pay for medical devices. However, accessing these systems effectively and efficiently is often far from clear to manufacturers. - [MDR & IVDR Tactical Session: working with a Notified Body](https://taoexcellence.ch/mdr-ivdr-tactical-session-working-with-a-notified-body/) - For many medtech companies, particularly SMEs, finding and working with a Notified Body can feel as far away as the moon. From the launch to your destination, we are sharing a workshop that can deliver greater insight... - [Evaluating your clinical data under the MDR](https://taoexcellence.ch/evaluating-your-clinical-data-under-the-mdr/) - The MDR has left many manufacturers wondering whether they have enough clinical data to certify their products in the EU. These regulatory changes are so wide and far reaching that it is difficult to... - [Evaluating your clinical data under the MDR](https://taoexcellence.ch/evaluating-your-clinical-data-under-the-mdr/) - The MDR has left many manufacturers wondering whether they have enough clinical data to certify their products in the EU. These regulatory changes are so wide and far reaching that it is difficult to... - [MDR und IVDR: Zusammenarbeit mit der benannten Stelle](https://taoexcellence.ch/mdr-ivdr-tactical-session-working-with-a-notified-body/) - Being able to find, connect to and work with an MDR designated Notified Body (NB) in a productive and effective way is one of the greatest concerns for many medtech companies, particularly SMEs. - [Medtech’s role in patient safety](https://taoexcellence.ch/medtech-role-in-patient-safety/) - Patient safety is key to strengthening and improving our healthcare systems, and medtech has a vital role to play in delivering this global health priority. - [Medtech’s role in patient safety](https://taoexcellence.ch/medtech-role-in-patient-safety/) - Patient safety is key to strengthening and improving our healthcare systems, and medtech has a vital role to play in delivering this global health priority. - [Tactical Session: MDSAP Gap Analysis - Dos and Don'ts](https://taoexcellence.ch/mdsap-gap-analysis-dos-and-donts/) - Sind Sie Teil der Gap-Analyse für ein MDSAP-Audit? In diesem Fall sind Sie hier richtig. - [Six Sigma Yellow Belt Kurs](https://taoexcellence.ch/six-sigma-yellow-belt-kurs/) - Die Teilnehmer lernen die Six Sigma Methodik kennen. Sie verstehen die einzelnen Phasen des DMAIC Zyklus und kennen 3-4 relevante und anwendbare Werkzeuge für jede Phase. - [Tactical Session: Wie bereiten Sie ein MDSAP Audit vor](https://taoexcellence.ch/how-to-prepare-an-mdsap-audit/) - Bereiten Sie sich darauf vor, bald ein MDSAP-Audit durchzuführen? In diesem Fall sind Sie hier richtig. - [Tactical Session: Antworten zum MDR Transfer Ihrer Produkte](https://taoexcellence.ch/what-to-consider-when-transitioning-products-to-mdr/) - Haben Sie manchmal auch das Gefühl, eine Möve zu sein, wenn es um die Transitionsstrategie Ihrer Produkte zur MDR geht? Falls ja, sind Sie hier richtig. - [Six Sigma Yellow Belt training for medical devices](https://taoexcellence.ch/six-sigma-yellow-belt-training-for-medical-devices/) - Date: 11th-12th September 2019 Location: Lucerne Please contact us for more information - [Six Sigma Yellow Belt training für Medizinprodukte](https://taoexcellence.ch/six-sigma-yellow-belt-training-for-medical-devices/) - Datum: 11.-12. September 2019 Ort: Luzern Bitte kontaktieren Sie uns für weitere Informationen - [Tactical Session: How to prepare an MDSAP Audit](https://taoexcellence.ch/how-to-prepare-an-mdsap-audit/) - Are you preparing to host an MDSAP audit soon? In this case, this is the event for you. - [Six Sigma Yellow Belt Kurs](https://taoexcellence.ch/six-sigma-yellow-belt-kurs/) - Die Teilnehmer lernen die Six Sigma Methodik kennen. Sie verstehen die einzelnen Phasen des DMAIC Zyklus und kennen 3-4 relevante und anwendbare Werkzeuge für jede Phase. - [Tactical Session: MDSAP Gap Analysis - Dos and Don'ts](https://taoexcellence.ch/mdsap-gap-analysis-dos-and-donts/) - Are you involved or performing a gap analysis for an MDSAP audit? In this case, this is the event for you. - [Tactical Session: What to consider when transitioning products to MDR](https://taoexcellence.ch/what-to-consider-when-transitioning-products-to-mdr/) - Do you sometimes also feel like a seagull when it comes to the transition strategy of your products to the MDR? If so, this is the event for you. - [Behind-the-scenes with Martina Ehrat](https://taoexcellence.ch/behind-the-scenes-with-martina-ehrat/) - Martina Ehrat has been a part of The Tao of Excellence since it began 4 years ago. Here, she talks to Henrietta Shirley about being a creative in medtech. - [Behind-the-scenes with Martina Ehrat](https://taoexcellence.ch/behind-the-scenes-with-martina-ehrat/) - Martina Ehrat has been a part of The Tao of Excellence since it began 4 years ago. Here, she talks to Henrietta Shirley about being a creative in medtech. - [The Medtech Diary: Swiss Digital Day](https://taoexcellence.ch/the-medtech-diary-swiss-digital-day/) - Next week, 3 September 2019, will be Swiss Digital Day—a national event initiated by digitalswitzerland to promote and support digitalisation across Switzerland. - [The Medtech Diary: Swiss Digital Day](https://taoexcellence.ch/the-medtech-diary-swiss-digital-day/) - Next week, 3 September 2019, will be Swiss Digital Day—a national event initiated by digitalswitzerland to promote and support digitalisation across Switzerland. - [Futureproofing Swiss healthcare](https://taoexcellence.ch/futureproofing-swiss-healthcare/) - Healthcare is basically a process industry. As any professional manager from such an industry would know, smooth procedures with a minimum of pause or interruption is key to keeping costs low! - [Futureproofing Swiss healthcare](https://taoexcellence.ch/futureproofing-swiss-healthcare/) - Healthcare is basically a process industry. As any professional manager from such an industry would know, smooth procedures with a minimum of pause or interruption is key to keeping costs low! - [Key research for medical device manufactures](https://taoexcellence.ch/key-research-for-medical-device-manufactures/) - How does regulation affect innovation? We are built to explore, to travel, to move forward. We have a drive to delve deeper than what we know, to improve upon what exists, to discover new spaces and revolutionize our present for the better. - [Key research for medical device manufactures](https://taoexcellence.ch/key-research-for-medical-device-manufactures/) - How does regulation affect innovation? We are built to explore, to travel, to move forward. We have a drive to delve deeper than what we know, to improve upon what exists, to discover new spaces and revolutionize our present for the better. - [Swiss take on big pharma and create new markets](https://taoexcellence.ch/swiss-take-on-big-pharma-and-create-new-markets/) - The top university hospitals in Switzerland may be on the verge of changing the face healthcare. Under the direction of the Swiss Association for Clinical Cancer Research (SAKK)... - [Swiss take on big pharma and create new markets](https://taoexcellence.ch/swiss-take-on-big-pharma-and-create-new-markets/) - The top university hospitals in Switzerland may be on the verge of changing the face healthcare. Under the direction of the Swiss Association for Clinical Cancer Research (SAKK)... - [The MedTech Diary: digital transformation and AI](https://taoexcellence.ch/the-medtech-diary-digital-transformation-and-ai/) - Digitalization, new software, data analytics and the increasing use of artificial intelligence (AI) in healthcare is touching and transforming every aspect of the medtech industry. - [The MedTech Diary: digital transformation and AI](https://taoexcellence.ch/the-medtech-diary-digital-transformation-and-ai/) - Digitalization, new software, data analytics and the increasing use of artificial intelligence (AI) in healthcare is touching and transforming every aspect of the medtech industry. - [The MedTech Diary: regulation and innovation](https://taoexcellence.ch/the-medtech-diary-regulation-and-innovation/) - We’ve collected the best dates in medtech coming up over the next few months to get you inspired and fired-up after the summer and keep you fully informed in advance of 2020. - [The MedTech Diary: regulation and innovation](https://taoexcellence.ch/the-medtech-diary-regulation-and-innovation/) - We’ve collected the best dates in medtech coming up over the next few months to get you inspired and fired-up after the summer and keep you fully informed in advance of 2020. - [The Basic UDI and its role](https://taoexcellence.ch/the-basic-udi-and-its-role/) - The Official Journal of the European Union (OJEU) has announced four UDI Issuing Entities for medical devices under the EU's MDR and IVDR. Here, we take a look at the “Basic UDI-DI” they will be in charge of... - [The Basic UDI and its role](https://taoexcellence.ch/the-basic-udi-and-its-role/) - The Official Journal of the European Union (OJEU) has announced four UDI Issuing Entities for medical devices under the EU's MDR and IVDR. Here, we take a look at the “Basic UDI-DI” they will be in charge of... - [Creating a data platform for MedTech](https://taoexcellence.ch/creating-a-data-platform-for-medtech/) - Data strategist Yannik Messerli on a new horizon in the MedTech industry and the development of a data platform designed for medical device manufactures. A landmark moment in MedTech, this platform will bring together... - [Creating a data platform for MedTech](https://taoexcellence.ch/creating-a-data-platform-for-medtech/) - Data strategist Yannik Messerli on a new horizon in the MedTech industry and the development of a data platform designed for medical device manufactures. A landmark moment in MedTech, this platform will bring together... - [Data science: a brave new world in MedTech](https://taoexcellence.ch/data-science-a-brave-new-world-in-medtech/) - With advances in technology—its wide use and global accessibility—data collection and its analysis is fast becoming one of the world’s most valuable assets. Mapping the world around us in real-time, informing our present... - [Data science: a brave new world in MedTech](https://taoexcellence.ch/data-science-a-brave-new-world-in-medtech/) - With advances in technology—its wide use and global accessibility—data collection and its analysis is fast becoming one of the world’s most valuable assets. Mapping the world around us in real-time, informing our present... - [The right time, the right team](https://taoexcellence.ch/the-right-time-the-right-team/) - Set up 4 years ago, Jasminka Roth has found herself and the company she’s created, The Tao of Excellence, working at the cutting edge of the MedTech industry and in a way made possible by today’s technology. - [The right time, the right team](https://taoexcellence.ch/the-right-time-the-right-team/) - Set up 4 years ago, Jasminka Roth has found herself and the company she’s created, The Tao of Excellence, working at the cutting edge of the MedTech industry and in a way made possible by today’s technology. - [Empower to improve: Six Sigma Part 2](https://taoexcellence.ch/empower-to-improve-six-sigma-part-2/) - Six Sigma is both a technique and a way of thinking that enables companies to create an environment of continuous improvement. It empowers and inspires individuals across an organisation to work together to find solutions... - [Empower to improve: Six Sigma Part 2](https://taoexcellence.ch/empower-to-improve-six-sigma-part-2/) - Six Sigma is both a technique and a way of thinking that enables companies to create an environment of continuous improvement. It empowers and inspires individuals across an organisation to work together to find solutions... - [Empower to improve: Six Sigma Part 1](https://taoexcellence.ch/empower-to-improve-six-sigma-part-1/) - Six Sigma is a methodology for the continuous improvement of processes and procedures. It is a technique and way of thinking that works from a baseline of statistical analysis and gives people the tools and... - [Empower to improve: Six Sigma Part 1](https://taoexcellence.ch/empower-to-improve-six-sigma-part-1/) - Six Sigma is a methodology for the continuous improvement of processes and procedures. It is a technique and way of thinking that works from a baseline of statistical analysis and gives people the tools and... - [From paper to eQMS: Part 2](https://taoexcellence.ch/from-paper-to-eqms-part-2/) - A seamless transition to the new regulatory requirements of the EU’s Medical Device Regulations (MDR) will be a significantly smoother process for those organisations that choose to implement an electronic Quality Management System (eQMS). - [From paper to eQMS: Part 2](https://taoexcellence.ch/from-paper-to-eqms-part-2/) - A seamless transition to the new regulatory requirements of the EU’s Medical Device Regulations (MDR) will be a significantly smoother process for those organisations that choose to implement an electronic Quality Management System (eQMS). - [Denis Vörös on the digital evolution of QMS](https://taoexcellence.ch/denis-voros-on-the-digital-evolution-of-qms/) - Quality Implementation Manager Denis Vörös talks to Henrietta Shirley about the digitalization of Quality Management Systems (QMS), and its renewed ability to lighten your workload.. - [The power of giving back](https://taoexcellence.ch/the-power-of-giving-back/) - We believe in giving back. We believe that generosity creates an environment of abundance, that it inspires a greater sense of connection and stronger engagement... - [Denis Vörös on the digital evolution of QMS](https://taoexcellence.ch/denis-voros-on-the-digital-evolution-of-qms/) - Quality Implementation Manager Denis Vörös talks to Henrietta Shirley about the digitalization of Quality Management Systems (QMS), and its renewed ability to lighten your workload.. - [Identify your PRRC](https://taoexcellence.ch/identify-your-prrc/) - The EU’s new Medical Device Regulation (MDR 2017/745) identifies the key requirements an organisation must look for in the person responsible for regulatory compliance (PRRC). - [Identify your PRRC](https://taoexcellence.ch/identify-your-prrc/) - The EU’s new Medical Device Regulation (MDR 2017/745) identifies the key requirements an organisation must look for in the person responsible for regulatory compliance (PRRC). - [From paper to eQMS: Part 1](https://taoexcellence.ch/from-paper-to-eqms-part-1/) - Surprisingly, for a sector widely associated with scientific discovery, innovation and cutting-edge technology, many organisations are still using a paper-based Quality Management System (QMS) rather than an electronic one (eQMS). - [From paper to eQMS: Part 1](https://taoexcellence.ch/from-paper-to-eqms-part-1/) - Surprisingly, for a sector widely associated with scientific discovery, innovation and cutting-edge technology, many organisations are still using a paper-based Quality Management System (QMS) rather than an electronic one (eQMS). - [MDSAP replaces CMDAS in Canada](https://taoexcellence.ch/mdsap-replaces-cmdas-in-canada/) - As announced for the first time by Health Canada in April 2016, the 1 January 2019 marked the official date that the country replaced its CMDCAS program with MDSAP! - [Governing by crisis](https://taoexcellence.ch/governing-by-crisis/) - The US government shutdown and its effect on medical device safety. This is now the longest government shutdown in US history. - [Improving for today and the future](https://taoexcellence.ch/improving-for-today-and-the-future/) - As we create, we hone our skills. During this process we begin to identify where we can improve or even innovate, and this relies on failure. - [Begin your data collection for the Eudamed today](https://taoexcellence.ch/begin-your-data-collection-for-the-eudamed-today/) - The European Databank on Medical Devices (Eudamed) will go live from the 25 March 2020. This database is essential to the functioning of the European Medical Devices Regulation and In-vitro Diagnostics Regulation. - [Yannik Messerli on the art of data](https://taoexcellence.ch/yannik-messerli-on-the-art-of-data/) - Henrietta Shirley talks to data strategist and infographic designer Yannik Messerli about mastering his art, the analysis and artwork of data. - [The power of giving back](https://taoexcellence.ch/the-power-of-giving-back/) - We believe in giving back. We believe that generosity creates an environment of abundance, that it inspires a greater sense of connection and stronger engagement... - [Embracing data collection for success](https://taoexcellence.ch/embracing-data-collection-for-success/) - Over the past few years alone, “digital healthcare has grown exponentially” and “the amount of data collected by the industry has increased by almost 50% every year.” - [MDSAP replaces CMDAS in Canada](https://taoexcellence.ch/mdsap-replaces-cmdas-in-canada/) - As announced for the first time by Health Canada in April 2016, the 1 January 2019 marked the official date that the country replaced its CMDCAS program with MDSAP! - [Governing by crisis](https://taoexcellence.ch/governing-by-crisis/) - As a sector, medical innovation is one of the fastest paced industries worldwide with the US positioned as the largest medical device market in the world—a market that is currently valued at an estimated $400 billion. - [Improving for today and the future](https://taoexcellence.ch/improving-for-today-and-the-future/) - As we create, we hone our skills. During this process we begin to identify where we can improve or even innovate, and this relies on failure. - [Secure your business in Europe through MDR compliance](https://taoexcellence.ch/secure-your-business-in-europe-through-mdr-compliance/) - The clock is ticking, and time is running out to prepare your organisations’ Medical Device Regulations (MDR) certification. - [Secure your business in Europe through MDR compliance](https://taoexcellence.ch/secure-your-business-in-europe-through-mdr-compliance/) - The clock is ticking, and time is running out to prepare your organisations’ Medical Device Regulations (MDR) certification. - [Begin your data collection for the Eudamed today](https://taoexcellence.ch/begin-your-data-collection-for-the-eudamed-today/) - The European Databank on Medical Devices (Eudamed) will go live from the 25 March 2020. This database is essential to the functioning of the European Medical Devices Regulation and In-vitro Diagnostics Regulation. - [Harnessing the power of market transparency](https://taoexcellence.ch/harnessing-the-power-of-market-transparency/) - New regulations and initiatives are being built in Europe to create a more transparent medical devices market. This presents not only the opportunity for gathering business intelligence that can develop and enhance any organization— - [Harnessing the power of market transparency](https://taoexcellence.ch/harnessing-the-power-of-market-transparency/) - New regulations and initiatives are being built in Europe to create a more transparent medical devices market. This presents not only the opportunity for gathering business intelligence that can develop and enhance any organization— - [Process mapping the route to compliance](https://taoexcellence.ch/process-mapping-the-route-to-compliance/) - The medical device industry is built on defined processes. These make sure that tasks are completed in a consistent, efficient and documented way, whilst also meeting the required regulatory compliance for this market. - [Process mapping the route to compliance](https://taoexcellence.ch/process-mapping-the-route-to-compliance/) - The medical device industry is built on defined processes. These make sure that tasks are completed in a consistent, efficient and documented way, whilst also meeting the required regulatory compliance for this market. - [Tracking the UDI System](https://taoexcellence.ch/tracking-the-udi-system/) - The Unique Device Identification (UDI) system defines the provenance of a medical device and tracks it through the healthcare system. - [Tracking the UDI System](https://taoexcellence.ch/tracking-the-udi-system/) - The Unique Device Identification (UDI) system defines the provenance of a medical device and tracks it through the healthcare system. - [Create a great Quality Management System](https://taoexcellence.ch/create-a-great-quality-management-system/) - Quality is not subjective but defined by that which brings it into being. Classically speaking, it’s about success, satisfaction, clarity, elegance... - [Create a great Quality Management System](https://taoexcellence.ch/create-a-great-quality-management-system/) - Quality is not subjective but defined by that which brings it into being. Classically speaking, it’s about success, satisfaction, clarity, elegance... - [Yannik Messerli on the art of data](https://taoexcellence.ch/yannik-messerli-on-the-art-of-data/) - Henrietta Shirley talks to data strategist and infographic designer Yannik Messerli about mastering his art, the analysis and artwork of data. - [5 Steps to an MDR Audit](https://taoexcellence.ch/5-steps-to-an-mdr-audit/) - As you read this, Notified Bodies (NB) are scheduling their first MDR audits—so we’ve defined 5 steps to how you can prepare for yours. - [5 Steps to an MDR Audit](https://taoexcellence.ch/5-steps-to-an-mdr-audit/) - As you read this, Notified Bodies (NB) are scheduling their first MDR audits—so we’ve defined 5 steps to how you can prepare for yours. - [Redefining distributors in a new light](https://taoexcellence.ch/redefining-distributors-in-a-new-light/) - The EU Commission’s new Medical Device Regulation (MDR) significantly changes the importance of economic operators in the healthcare industry and their responsibility in protecting patient safety. - [Redefining distributors in a new light](https://taoexcellence.ch/redefining-distributors-in-a-new-light/) - The EU Commission’s new Medical Device Regulation (MDR) significantly changes the importance of economic operators in the healthcare industry and their responsibility in protecting patient safety. - [Taking a closer look at the MDR](https://taoexcellence.ch/taking-a-closer-look-at-the-mdr/) - When the new MDR was first announced in May 2017, we saw it at a distance. It would take three years until its implementation in May 2020.. - [Taking a closer look at the MDR](https://taoexcellence.ch/taking-a-closer-look-at-the-mdr/) - When the new MDR was first announced in May 2017, we saw it at a distance. It would take three years until its implementation in May 2020.. - [How to perform a gap analysis in the current market](https://taoexcellence.ch/how-to-perform-a-gap-analysis-in-the-current-market/) - Analysing where you are so that you can see where you are going—and beyond that where you can go—is an important practice for any individual or business. - [How to perform a gap analysis in the current market](https://taoexcellence.ch/how-to-perform-a-gap-analysis-in-the-current-market/) - Analysing where you are so that you can see where you are going—and beyond that where you can go—is an important practice for any individual or business. - [Embracing data collection for success](https://taoexcellence.ch/embracing-data-collection-for-success/) - Over the past few years alone, “digital healthcare has grown exponentially” and “the amount of data collected by the industry has increased by almost 50% every year.” - [The MDR with one year to go](https://taoexcellence.ch/the-mdr-with-one-year-to-go/) - Next week, it will be exactly 1 year until the EU Commission’s (EC) new Medical Device Regulations (MDR) become applicable. - [The MDR with one year to go](https://taoexcellence.ch/the-mdr-with-one-year-to-go/) - Next week, it will be exactly 1 year until the EU Commission’s (EC) new Medical Device Regulations (MDR) become applicable. ## Pages - [Home](https://taoexcellence.ch/) - Delivering Solutionscompliance, certification, market insights, commercial successMore infoShopdownloadable tools and easy-access compliance servicesMore infoEnsuring Audit Readinessensure a smooth, successful and efficient audit and market accessMore infoSmart Process Designsafer, faster and more cost-effective processesMore info “We had a very successful audit… Only one deviation (and one really be sought for). 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Einleitung Wir freuen uns über Ihren Besuch unserer Webseite. Im Folgenden informieren wir Sie darüber, welche personenbezogenen Daten wir erheben und was mit diesen Daten passiert, wenn Sie unsere Webseite besuchen. Personenbezogene Daten sind solche Informationen, die Sie als Person identifizieren oder identifizieren können. Weiterhin erläutern wir, - [Offene Stellen](https://taoexcellence.ch/?page_id=5296) - We are hiring! We have two internship positions to offer. Do you want to join a motivated, dynamic, and open team? We are specialist consultants for the medical devices and pharmaceutical industry. ● Start: immediately ● Duration: 6 months ● Volume: 20% (8h a week) Job description Are you interested and the description fits your profile? 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From data and gap analysis to securing a successful regulatory strategy and implementation of a high-performance and sustainable QMS (Quality Management System), The Tao of Excellence - [Über uns](https://taoexcellence.ch/about/) - The Tao of Excellence Spezialisierte Fachpersonen für die Medizinproduktebranche mit einem Expertenteam aus der Schweiz, das Ihre regulatorische Strategie und Umsetzung der MDR (Medical Device Regulation) und IVDR (In-Vitro Device Regulation) in Europa und MDSAP (Medical Device Single Audit Program) in den entsprechenden Regionen unterstützen kann. 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I was able to absorb a lot of knowledge on the coaching days and then apply it.” Shift Supervisor, SME The Tao of Excellence provides Six Sigma training courses at White, Yellow and Green Belt levels and coaching at Black Belt level. Clients can book a private course tailored to - [Home](https://taoexcellence.ch/) - LösungenSichern Sie Ihren Erfolg, Ihre Compliance und Zertifizierung.Machen Sie mit unseren Fachkenntnissen, digitalen Anwendungen, Managementsystemen,Schulungen und Prozessentwicklungen das Beste aus Ihrem Business.WeiterlesenAudit-BereitschaftBestehen Sie Ihr Audit reibungslos, effizient und erfolgreich.Wir überprüfen Ihre regulatorischen Anforderungenund Ihrer Auditbereitschaft.WeiterlesenIntelligente ProzesseNutzen Sie unsere Branchen-, System- und Managementkompetenz,Entwerfen und entwickeln Sie die besten Systeme, Strategienund Schulungen, um Ihr Business zu optimieren.um - [Reflections](https://taoexcellence.ch/reflections/) - Unsere Experten erstellen Artikel und Interviews, die die aktuelle regulatorische Landschaft widerspiegeln und klare und präzise Anleitungen zu den Schritten geben, die Sie unternehmen können, um Ihre Zertifizierung sicherzustellen und Ihre Geschäftsstrategie und -verfahren zu optimieren. 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We provide: Evaluations of the relevant regulatory landscape. Product portfolio analysis to develop your Quality Management System and the best strategies to meet your regulatory requirements. Business development strategies and tactical advice. Specialist expertise - [Funding](https://taoexcellence.ch/funding/) - We believe in giving back. We understand that generosity inspires greater connection, stronger engagement, enhances well-being and increases productivity. For us, generosity is a value that brings our team together, connects us to the meaning behind the work we do, and supports the positive impact we want to cultivate in our work and the world - [Compliance und Audit-Vorbereitung](https://taoexcellence.ch/compliance-and-audit-preparation/) - Wir sind hier, um einen reibungslosen und effizienten Audit-Prozess für Ihre Organisation bereitzustellen, der eine erfolgreiche Bewertung und Zertifizierung gewährleistet. Wir können: Sie und Ihr Team unterstützen die Audit Kapazität und Compliance zu erreichen. Ihr Audit vorbereiten einschließlich Teamschulung und praktischer Unterstützung. Die optimale Auditing-Taktik entwickeln und spezialisiertes Coaching bereitstellen vor, während und nach Ihrem - [Compliance and Audit Preparation](https://taoexcellence.ch/compliance-and-audit-preparation/) - We are here to guide you through a smooth and efficient audit process, ensuring your company’s compliance and its successful evaluation and certification. We can: Ensure your audit capacity and compliance together with your team. Prepare your audit, including team training and hands-on support. Develop your auditing tactics, with specialist coaching before, during and after - [Strategische Intelligenz](https://taoexcellence.ch/strategic-intelligence/) - Wir sind hier, um sicherzustellen, dass Sie und Ihre Organisation über alle Informationen verfügt, die für fundierte Geschäftsentscheidungen erforderlich sind. Wir bieten: Evaluation der regulatorischen Landschaft. Produktportfolio-Analyse zur Entwicklung Ihres Qualitätsmanagementsystems und der besten Strategien, um Ihre regulatorischen Anforderungen zu erfüllen. Geschäftsentwicklungsstrategien und taktische Beratung. Fachexpertise in Europa, USA, Kanada, Brasilien, Japan und Australien. “…es - [MRA Solutions Finder](https://taoexcellence.ch/mra-solutions-finder/) - MRA Solutions Finder 600 CHF plus VAT This document is designed to help Swiss medical device manufacturers prepare for the regulatory scenarios they face with the renewal of the Mutual Recognition Agreement (MRA) uncertain before the new Medical Device Regulation (MDR) in the EU will apply from 26 May 2020. The solution finder will help you to - [Solutions test](https://taoexcellence.ch/?page_id=3775) - Access our services for support with your MDR, IVDR, MDSAP compliance and medical devices certification, business intelligence, audit preparation and the improvement and digitalization of your processes and procedures. From data and gap analysis to securing a successful regulatory strategy and implementation of a high-performance and sustainable QMS (Quality Management System), The Tao of Excellence - [Order tracking](https://taoexcellence.ch/order-tracking/) - [Order tracking](https://taoexcellence.ch/order-tracking/) - [My account](https://taoexcellence.ch/my-account/) - [Checkout](https://taoexcellence.ch/checkout/) - [Cart](https://taoexcellence.ch/cart/) - [Funding](https://taoexcellence.ch/funding/) - Die Kraft des Gebens Wir glauben daran, etwas zurückzugeben. Wir sind uns bewusst, dass Großzügigkeit zu einer stärkeren Verbindung, stärkerem Engagement, mehr Wohlbefinden und höherer Produktivität führt. Großzügigkeit ist eines der einfachsten, am einfachsten zugänglichen und effektivsten Werkzeuge, die uns zur Verfügung stehen. Sie hat die Fähigkeit, eine Umgebung des Überflusses zu schaffen, und ihre - [Prozess-Engineering](https://taoexcellence.ch/process-engineering/) - Wir sind hier, um Strategien zu entwickeln, die die Leistung Ihres Unternehmens optimieren und so für die Zukunft wappnen. Wir bieten: Führung und Unterstützung für kontinuierliche Verbesserungsaktivitäten. Coaching und Unterstützung bei Six-Sigma- und Lean-Six-Sigma-Initiativen. Training für innerbetriebliches Wachstum durch: Six Sigma Green Belt, Yellow Belt und White Belt Kurse Vertiefungskurse in spezifischen Modulen Spezialisiertes Bewusstsein - [Process Engineering](https://taoexcellence.ch/process-engineering/) - We are here to develop strategies that will optimise the performance of your organisation and secure its future. We deliver: Leadership and support for continuous improvement activities. Coaching and support in Six Sigma and Lean Six Sigma initiatives. Training for in-house growth via: Six Sigma Green, Yellow and White Belt Courses In-depth courses in specific - [MDSAP](https://taoexcellence.ch/mdsap/) - Hi there, I’m Jane Doe and I design things Few things about me On such a little thing my life hung that I often marvel that I escaped so easily. Had not the rifle of the leader of the party swung from its fastenings beside his saddle in such a way as to strike against - [MDSAP](https://taoexcellence.ch/mdsap/) - Hi there, I’m Jane Doe and I design things Few things about me On such a little thing my life hung that I often marvel that I escaped so easily. Had not the rifle of the leader of the party swung from its fastenings beside his saddle in such a way as to strike against - [MDR / IVDR](https://taoexcellence.ch/mdr-ivdr/) - Hi there, I’m Jane Doe and I design things Few things about me On such a little thing my life hung that I often marvel that I escaped so easily. Had not the rifle of the leader of the party swung from its fastenings beside his saddle in such a way as to strike against - [MDR / IVDR](https://taoexcellence.ch/mdr-ivdr/) - Hi there, I’m Jane Doe and I design things Few things about me On such a little thing my life hung that I often marvel that I escaped so easily. Had not the rifle of the leader of the party swung from its fastenings beside his saddle in such a way as to strike against - [Disclaimer](https://taoexcellence.ch/disclaimer/) - Home page Picture n°: 556800751, Author: Vixit, License: Free of Right, Source: Shutterstock.com Picture n°: 310254482, Author: Alvov, License: Free of Right, Source: Shutterstock.com Picture n°: 559844623, Author: Syda Productions, License: Free of Right, Source: Shutterstock.com Picture n°: 167797727, Author: Sanyanwuji, License: Free of Right, Source: Shutterstock.com Picture n°: Combination Products, Author: unknown, License: Free - [404](https://taoexcellence.ch/404-2/) - 404: Seite nicht gefunden Halten Sie Ruhe und machen weiter Zurück zur Startseite - [404](https://taoexcellence.ch/404-2/) - 404: PAGE NOT FOUND keep calm and carry on GO BACK TO THE HOME PAGE - [Kurse & Veranstaltungen](https://taoexcellence.ch/kurse-und-veranstaltungen/?lang=de) - Hi there, I’m Jane Doe and I design things Few things about me On such a little thing my life hung that I often marvel that I escaped so easily. Had not the rifle of the leader of the party swung from its fastenings beside his saddle in such a way as to strike against ## Services - [Pharmaceuticals](https://taoexcellence.ch/our-services/pharmaceuticals/) - Complex processes within a highly regulated environment make it increasingly difficult to implement improvement or innovation. Reach your project objectives and optimize your Quality Management System. - [Combination Products](https://taoexcellence.ch/our-services/combination-products/) - Technology is progressing at an unprecedented rate. Novel and innovative products require a more integrated approach to process development. Secure your compliance and the sustainability of your products and processes. - [Medical Devices](https://taoexcellence.ch/our-services/medical-devices/) - Recent and steep increases in regulatory requirements is reshaping the medical device industry. Compliance has never been so complex or costly. Ensure that you are properly informed and prepared for the new regulations such as the European Medical Device Regulations (MDR) and Medical Device Single Audit Program (MDSAP). - [Medizinprodukte](https://taoexcellence.ch/our-services/medical-devices/) - Stark steigende regulatorische Anforderungen verändern die Medizinprodukteindustrie. Compliance war noch nie so komplex oder kostspielig. Stellen Sie durch uns sicher, dass Sie gut informiert sind und auf die neuen Anforderungen wie die neue EU Verordnung für Medizinprodukte (MDR) und das Single Device Audit-Programm (MDSAP) vorbereitet sind. - [Pharmazeutika](https://taoexcellence.ch/our-services/pharmaceuticals/) - Komplexe Prozesse in einem stark regulierten Umfeld machen es zunehmend schwieriger, Verbesserungen oder Innovationen umzusetzen. Erreichen Sie Ihre Projektziele und optimieren Sie Ihr Qualitätsmanagementsystem. - [Kombinationsprodukte](https://taoexcellence.ch/our-services/combination-products/) - Die Technologie entwickelt sich in beispielloser Geschwindigkeit. Neuartige und innovative Produkte erfordern einen stärker integrierten Ansatz für die Prozessentwicklung. Sichern Sie Ihre Compliance und die Nachhaltigkeit Ihrer Produkte und Prozesse. ## Staff - [Ekaterina Rakhmatullina](https://taoexcellence.ch/our-team/ekaterina-rakhmatullina/) - Breite interdisziplinäre Erfahrung mit Medizinprodukten (IVD, MD) mit den Schwerpunkten Materialwissenschaft, Chemie, Verpackungsentwicklung und -validierung, Analysemethoden, IVD-Reagenzien, Qualitätsmanagement (QM) und Chemikaliengesetzgebung (REACH, RoHS). Die Kombination aus Führungs- und Projektmanagementfähigkeiten, Kenntnissen der QM- / regulatorischen Anforderungen und technischem Know-How ermöglichte die erfolgreiche Entwicklung von Medizinprodukten und IVD-Reagenzien in multikulturellen internationalen Settings. Sie schätzt pragmatisches Denken, offene Kommunikation und Teamarbeit auf allen Ebenen. Das Erforschen neuer Kulturen, Traditionen und das Entdecken neuer Orte auf der ganzen Welt nährt ihre Energie. Meditation, Mineralien und Astrologie helfen bei Ihrer positiven Einstellung. - [Ekaterina Rakhmatullina](https://taoexcellence.ch/our-team/ekaterina-rakhmatullina/) - Broad cross-disciplinary experience in medical devices (IVD, MD) with the focus in material science, chemistry, packaging development and validation, analytical methods, IVD reagents, quality management (QM) and chemical legislation (REACH, RoHS). Combination of strong leadership and project management skills, knowledge of QM/Regulatory requirements and technical know-how allowed successful development of medical devices and IVD reagents in multicultural international industries. She values pragmatic thinking, open communication and teamwork at all levels. Exploring new cultures, traditions and discovery of new places around the globe charge her batteries and fulfill the curious mind. Meditation, minerals and astrology help to maintain her positive attitude. - [Jasminka Roth](https://taoexcellence.ch/our-team/jasminka-roth/) - Proven track record in establishing and maintaining a quality system within the medical device environment (50 + audits). Longterm experience as a leader for the quality management and business excellence in multiple dynamic international companies within the manufacturing industry, where accuracy, reliability and negotiation skills are of particular importance. She enjoys spending time in nature with her family and is engaged in yoga practice since 2002. She is fluent in German, English, Croatian and speaks a little French. - [Martina Ehrat](https://taoexcellence.ch/our-team/martina-ehrat/) - Interest in precise work and visual skills led her to the watch industry and to more and more free artistic work later on. With creativity and a keen eye on the visual aspects, she helps to reach an optimal goal. Successful project management in companies of all sizes and as a self-employed person form the basics of her skill set. She supports the team in administrative and organizational matters. She enjoys spending her free time with her family, in nature and on cultural venues. She is fluent in German, English, and speaks a little French and Spanish. - [Deepa Rajagopalan](https://taoexcellence.ch/our-team/deepa-rajagopalan/) - Wide international experience on all facets of the quality spectrum across automotive, aerospace and medical device industries. Successfully scaled up organisations of varied sizes in the journey of audit readiness (40+ audits) by establishing end to end quality systems complemented by robust people transformation initiatives. She enjoys listening to music, playing the piano and exploring new travel destinations. She is conversant in English, German, Tamil and Hindi. - [Yannik Messerli](https://taoexcellence.ch/our-team/yannik-messerli/) - Creative and passionate developer with a strong focus towards delivering user-need driven solutions. He has led several innovative projects delivering to a tight time schedule. He has several years of experience as a data analyst for international IT companies, implementing scalable machine learning algorithms, applying sophisticated statistical techniques, extracting actionable knowledge from (big) data, and creating graphics to enable insights to executive stakeholders and partners. He enjoys rock climbing and ski touring and will take the opportunity whenever possible. He is fluent in French and English and speaks a little German. - [Julia Böttcher](https://taoexcellence.ch/our-team/julia-bottcher/) - Julia’s interest in the well-being of others, her volunteer work and analytical way of thinking led her to a professional career in the legal system at a number of renowned law firms. Her open-minded and communicative nature, as well as her organizational talent, eye for accuracy and a familiarity with office processes, makes Julia a key contributor to our team’s human resources and other administrative and organisational projects. Julia speaks German, English and some French, is an active traveller and interested in sports and making music, and enjoys spending her free time with her family and in the country. - [Große Unternehmen](https://taoexcellence.ch/our-team/large-enterprises/) - “Machen Sie sich bereit für die Zukunft” Strategische Beratung Digitale Projekte Projektmanagement Verbesserungsprojekte Innovationsmanagement MDR- und IVDR-Zertifizierung MDSAP-Zertifizierung - [Startups](https://taoexcellence.ch/our-team/start-ups/) - “Sicherstellung der Compliance von Anfang an” Einrichtung des vollständigen Qualitätsmanagementsystems (QMS) Verlässlicher Kontakt und Unterstützung für alle qualitätsbezogenen Themen Zertifizierung nach ISO9001 und ISO13485 MDR- und IVDR-Zertifizierung MDSAP-Zertifizierung - [KMUs](https://taoexcellence.ch/our-team/smes/) - “Gesundes und nachhaltiges Wachstum” Den Marktzugang aufrechterhalten Interim Management Zertifizierung nach ISO9001 und ISO13485 Geschäftsentwicklung Strategische Beratung MDR- und IVDR-Zertifizierung MDSAP-Zertifizierung - [SMEs](https://taoexcellence.ch/our-team/smes/) - “Healthy and sustainable growth” Sustaining market access Interim Management ISO9001 and ISO13485 certification Business development Strategic advice MDR and IVDR certification MDSAP certification - [Large enterprises](https://taoexcellence.ch/our-team/large-enterprises/) - “Get ready for the future” Strategic advice Digital projects Project management Improvement projects Innovation management MDR and IVDR certification MDSAP certification - [Start ups](https://taoexcellence.ch/our-team/start-ups/) - “Secure compliance from the start” Complete Quality Management System (QMS) setup Reliable contact and support for all quality related topics ISO9001 and ISO13485 certification MDR and IVDR certification MDSAP certification - [Julia Böttcher](https://taoexcellence.ch/our-team/julia-bottcher/) - Ehrenamtliche Tätigkeiten durch Interesse am Wohl des Mitmenschen und analytisches Denken, führten sie in den Anfängen ihrer beruflichen Laufbahn in das Rechtswesen bei renommierten Kanzleien. Mit ihrer aufgeschlossenen und kommunikativen Persönlichkeit gepaart mit organisatorischem Talent, Blick für Genauigkeit und Vertrautheit mit Büroabläufen, unterstützt sie das Team im Human Resources Bereich und als Allrounderin. Ihre Freizeit verbringt sie gerne mit Ihrer Familie und im Grünen. Sie reist leidenschaftlich gerne, treibt Sport und musiziert. Sie spricht Deutsch, Englisch und etwas Französisch. - [Henrietta Shirley](https://taoexcellence.ch/our-team/henrietta-shirley/) - A creative, versatile and accomplished editor, Henrietta has over eight years of experience working as a writer, editor and project manager for a wide range of clients and companies. Before becoming a freelance writer, Henrietta was a specialist proposals writer and project manager at the international art auction house Sotheby's, business-getting high-value works for their global auctions. Since 2018, Henrietta has begun editing scientific papers for a leading university in London as well as working as an editor in the field medical devices. She enjoys research, art, literature, yoga and being in nature. - [Henrietta Shirley](https://taoexcellence.ch/our-team/henrietta-shirley/) - Als kreative, vielseitige und versierte Redakteurin verfügt Henrietta über mehr als acht Jahre Erfahrung als Autorin, Redakteurin und Projektmanagerin für eine Vielzahl von Kunden und Unternehmen. Bevor sie freiberufliche Autorin wurde, war Henrietta Fachautorin für Vorschläge und Projektmanagerin beim internationalen Kunstauktionshaus Sotheby's, das hochwertige Werke für ihre weltweiten Auktionen anbot. Seit 2018 redigiert Henrietta wissenschaftliche Artikel für eine führende Universität in London und arbeitet als Redakteurin im Bereich Medizinprodukte. Sie liebt Forschung, Kunst, Literatur, Yoga und Natur. - [Lassana Diabira](https://taoexcellence.ch/our-team/lassana-diabira/) - Passionate about building data driven algorithms to solve challenging business problems. Loves to develop AI solutions that increase business value by simplifying complexities and discovering underlying patterns in data. He has 2+ years of experience as a Data Scientist and has successfully built and deployed scalable machine learning algorithms for different companies. He enjoys boxing, playing football and travelling. He is fluent in French, English and speaks a little Spanish. - [Lassana Diabira](https://taoexcellence.ch/our-team/lassana-diabira/) - Entwickelt mit Leidenschaft datengetriebene Algorithmen, um herausfordernde Geschäftsprobleme zu lösen. Liebt es, AI-Lösungen zu entwickeln, welche wertschöpfend sind, indem sie die Komplexität vereinfachen und Muster in Daten sichtbar machen. Er verfügt über mehr als zwei Jahre Erfahrung als Data Scientist und hat erfolgreich skalierbare Algorithmen für maschinelles Lernen für verschiedene Unternehmen entwickelt und implementiert. Er boxt gern, spielt Fußball und reist gern. Er spricht Französisch, Englisch und etwas Spanisch. - [Yannik Messerli](https://taoexcellence.ch/our-team/yannik-messerli/) - Kreativer und leidenschaftlicher Entwickler mit starkem Fokus auf kundenorientierte Lösungen. Er hat mehrere innovative Projekte geleitet, auch mit engem Zeitplan. Er hat mehrjährige Erfahrung als Datenanalyst für internationale IT-Unternehmen, Implementierung skalierbarer Algorithmen für ‘machine learning’, Anwendung ausgefeilter statistischer Techniken, Extraktion von Einsichten aus (big) Data und Erstellung von Grafiken, um die Erkenntnisse visuell für Kunden und Partnern zu ermöglichen. Er liebt das Klettern und geht - wenn immer möglich - auf Skitouren. Er spricht fließend Französisch und Englisch und ein wenig Deutsch. - [Deepa Rajagopalan](https://taoexcellence.ch/our-team/deepa-rajagopalan/) - Umfangreiche internationale Erfahrung in allen Facetten des Qualitätsspektrums in der Automobil, Luftfahrt und Medizinproduktindustrie. Erfolgreiches Führen von Organisationen unterschiedlicher Grösse bis zur Auditbereitschaft (40+ Audits) durch Implementierung von Qualitätsmanagementsystemen ergänzt durch tiefreichende Transformationsinitiativen mit den betroffenen Menschen. Sie hört gerne Musik, spielt Klavier und entdeckt neue Reiseziele. Sie spricht Englisch, Deutsch, Tamilisch und Hindi. - [Martina Ehrat](https://taoexcellence.ch/our-team/martina-ehrat/) - Interesse an genauem Arbeiten und visuellem Geschick führten sie schon früh in die Uhrenindustrie und später vermehrt zu freien künstlerischen Arbeiten. Mit gestalterischem Geschick, Kreativität und scharfem Blick auf das Visuelle, hilft sie mit, ein optimales Ziel zu erreichen. Erfolgreiche Projektleitung in Betrieben aller Grössen und auch als Selbständige sind die Grundlage für ihr Geschick. Sie unterstützt das Team in administrativen und organisatorischen Belangen. Ihre Freizeit verbringt sie mit der Familie, in der Natur und an kulturellen Anlässen. Sie spricht Deutsch, Englisch, etwas Französisch und etwas spanisch. - [Jasminka Roth](https://taoexcellence.ch/our-team/jasminka-roth/) - Erfolgreiche Entwicklung, Einführung und Management der Qualitätsabteilung und der Qualitätssysteme (50+ Audits) in einem sehr dynamischen und internationalen Umfeld der Medizinprodukteindustrie. Verlässliche und kommunikative Persönlichkeit mit langjähriger Führungserfahrung im Bereich Qualitätsmanagement und Business Excellence in mehreren dynamischen internationalen Unternehmen, wo Genauigkeit, Zuverlässigkeit und Verhandlungsgeschick von besonderer Bedeutung sind. Sie verbringt gerne Zeit in der Natur und mit ihrer Familie und übt seit 2002 Yoga. Sie spricht Deutsch, Englisch, Kroatisch und etwas Französisch. ## Swatches - [Gray](https://taoexcellence.ch/oxy_swatch/gray/) - [White](https://taoexcellence.ch/oxy_swatch/white/) - [Blue](https://taoexcellence.ch/oxy_swatch/blue/) - [ToEX Blue](https://taoexcellence.ch/oxy_swatch/toex-blue/) - [White/Red](https://taoexcellence.ch/oxy_swatch/white-red/) - [Black](https://taoexcellence.ch/oxy_swatch/black/) - [White/Black](https://taoexcellence.ch/oxy_swatch/white-black/) - [White/Green](https://taoexcellence.ch/oxy_swatch/white-green/) ## Products - [Regulatory document matrix for medical devices

For the EU and Swiss market

](https://taoexcellence.ch/product/regulatory-document-matrix-for-medical-devices/) - Download of document matrix for immediate use. MDR und MedDO requirements and references to the relevant articles. Understanding through description of each relevant regulatory document. Highlighting of Switzerland specific requirements. Basis for comparing the required documents based on risk class of device. Customizable in Microsoft Word or Apple Pages format. - [Importer Manual for Switzerland

Conformity without a certified QMS.

](https://taoexcellence.ch/product/importer-manual-for-switzerland/) - Download of manual for immediate use. MepV und MDR conformity for importers to Switzerland. Dokumentation of all activities a spart of the importer role. Conformity through complete description of implementation. Basis for audits by Swissmedic. Customizable in Microsoft Word or Apple Pages format. - [CH-REP Manual for Switzerland

Conformity without a certified QMS.

](https://taoexcellence.ch/product/ch-rep-manual-for-switzerland/) - Download of manual for immediate use. MepV und MDR conformity for CH-REPs to Switzerland. Documentation of all activities in the CH-REP role. Conformity through complete description of implementation. Basis for audits by Swissmedic. Customizable in Microsoft Word or Apple Pages format. - [Checklist for label

for medical devices in EU and Switzerland.

](https://taoexcellence.ch/product/checklist-for-label/) - Download of checklist for immediate use. MDR und MepV compliant checklist for manufacturers in EU and Switzerland. Conformity check through detailed listing of requirements. Basis for reviewing compliance of label with regulation. Customizable in Microsoft Word or Apple Pages format. - [Importer Training

For Swiss Importers

](https://taoexcellence.ch/product/importer-training/) - 490 CHF / Person Online access and on demand Swiss focus MedDO requirements and corresponding MDR references Modular design to allow a digestible approach Experience based relevance of content Certificate after successful completion Contact us - [Importeur Kurs

Für Schweizer Importeure

](https://taoexcellence.ch/product/importer-training/) - 490 CHF / Person Online-Zugang nach Bedarf Schweizer Fokus MepV Anforderungen und entsprechende MDR-Verweise Modulares Design für einen verdaubaren Ansatz Erfahrungsbasierte Relevanz des Inhalts Zertifikat nach erfolgreichem Abschluss Kontaktieren Sie uns - [Regulatorische Dokumentenmatrix für Medizinprodukte

Für den EU- und Schweizer Markt

](https://taoexcellence.ch/product/regulatory-document-matrix-for-medical-devices/) - Download der Dokumentenmatrix zum sofortigen Gebrauch. MDR und MepV Anforderungen und Referenzen zum relevanten Artikel. Verständnis durch Beschreibung der einzelnen relevanten regulatorischen Dokumente. Hervorhebung der schweiz-spezifischen Anforderungen. Grundlage für den Vergleich der erforderlichen Dokumente basierend auf der Risikoklasse des Produkts. Anpassungsfähig im Microsoft Word oder Apple Pages Format. - [Checkliste zur konformen Kennzeichnung

von Medizinprodukten in EU und der Schweiz.

](https://taoexcellence.ch/product/checklist-for-label/) - Download der Checkliste ermöglicht die sofortige Nutzung. MDR und MepV konforme Checkliste für Hersteller in der EU und der Schweiz. Konformitätsprüfung durch detaillierte Auflistung der Anforderungen. Grundlage für die Überprüfung der Konformität des Etiketts mit der Verordnung. Anpassungsfähig im Microsoft Word oder Apple Pages Format. - [CH-REP Handbuch für die Schweiz

Konformität ohne zertifiziertes QMS.

](https://taoexcellence.ch/product/ch-rep-manual-for-switzerland/) - Download des Handbuchs ermöglicht die sofortige Nutzung. MepV und MDR Konformität für CH-REPs in der Schweiz. Dokumentation aller Aktivitäten im Rahmen der CH-REP-Rolle. Konformität durch vollständige Beschreibung der Umsetzung. Grundlage für Audits durch Swissmedic. Anpassungsfähig im Microsoft Word oder Apple Pages Format. - [Importeurhandbuch für die Schweiz

Konformität ohne zertifiziertes QMS.

](https://taoexcellence.ch/product/importer-manual-for-switzerland/) - Download des Handbuchs ermöglicht die sofortige Nutzung. MepV und MDR Konformität für Importeure in der Schweiz. Dokumentation aller Aktivitäten im Rahmen der Importeur-Rolle. Konformität durch vollständige Beschreibung der Umsetzung. Grundlage für Audits durch Swissmedic. Anpassungsfähig im Microsoft Word oder Apple Pages format. - [MDR Clinical Evaluation

Gap analysis tool for GCP compliance.

](https://taoexcellence.ch/product/mdr-clinical-practice/) - Downloadable excel file that is clear, accessible and easy-to-use. MDR and ISO 14155:2020 (GCP) compliance checklist of MDR requirements for clinical investigations. Gap analysis tool to show you how compliant your SOPs are against individual standards and MDR requirements for clinical investigations. Identify an action plan using the checklist of tasks to complete to achieve compliance Review and track SOP compliance with a % table summary measuring how complete the update is. Maintain 100% compliance by using this tool after your SOP updates to ensure continued compliance. - [ISO 9001 Starter Kit

Set up a new quality management system.

](https://taoexcellence.ch/product/iso-9001-starter-kit/) - Build a strong and certified QMS tailored to your business needs. Compliant, efficient and agile processes delivered using the expertise and experience of regulatory specialists. 2-hour consultation call to assess and tailor ISO 9001 requirements to your business. 4-hour on-site workshop to confirm your process map and implementation strategy. 2-hour training session for your team in the QMS basics and check implementation status. 4-hour mock audit to confirm system readiness and ensure certification. - [ISO 13485 Starter Kit

The QMS for your medical device.

](https://taoexcellence.ch/product/iso-13485-starter-kit/) - Build a strong QMS tailored to your business needs. Secure ISO 13485 certification with a system designed using our longstanding regulatory expertise and experience. 2-hour consultation call to assess and tailor relevant QMS elements to your business and confirm the content for your system. 4-hour on-site workshop to develop the QMS process map and confirm the implementation strategy. 2-hour training session for your team in the QMS and audit process. 4-hour mock audit to confirm system readiness and ensure certification. - [MRA Solutions Finder

Tool to optimize preparation for a missing MRA.

](https://taoexcellence.ch/product/mra-solutions-finder/) - Downloadable excel file that can calculate and prioritise the right solutions for your business. A final regulatory strategy prioritised by price, time and site-specific insights. 3-hour consultation to optimise your use of this tool and answer regulatory questions. Clearly defined MRA / MDR scenarios with the regulatory requirements for each area. A checklist of all the solutions and the steps to consider. Inbuilt formula to calculate which tasks to complete first. Insight from your team integrated into the formula to prioritise tasks. - [ISO 9001 Starter-Kit

Zertifizierung in 8 Wochen.

](https://taoexcellence.ch/product/iso-9001-starter-kit/) - Erstellen Sie ein starkes und zertifiziertes QMS, das auf Ihre Geschäftsanforderungen zugeschnitten ist. Konforme, effiziente und agile Prozesse, die mit dem Fachwissen und der Erfahrung von Regulierungsspezialisten geliefert werden. 2-stündiges Beratungsgespräch zur Bewertung und Anpassung der ISO 9001-Anforderungen an Ihr Unternehmen. 4-stündiger Vor-Ort-Workshop zur Bestätigung Ihres Prozessplanes und Ihrer Umsetzungsstrategie. 2-stündige Schulung zur Unterstützung Ihres Teams in den QMS-Grundlagen und der Überprüfung des Implementierungstatus. 4-stündiges Mock-Audit zur Bestätigung der Systembereitschaft und zur Sicherstellung der Zertifizierung. - [ISO 13485 Starter-Kit

Das QMS für Ihr Medizinprodukt.

](https://taoexcellence.ch/product/iso-13485-starter-kit/) - Erstellen Sie ein starkes QMS, das auf Ihre Geschäftsanforderungen zugeschnitten ist. Sichern Sie sich die ISO 13485-Zertifizierung mit einem System, das auf unserer langjährigen Erfahrung und unseren Fachkenntnissen im Bereich der Regulierung basiert. 2-stündiger Beratungsaufruf zur Bewertung und Anpassung relevanter QMS-Elemente an Ihr Unternehmen und zur Bestätigung des Inhalts für Ihr System. 4-stündiger Vor-Ort-Workshop zur Entwicklung des QMS-Prozessplanes und zur Bestätigung der Implementierungsstrategie. 2-stündige Schulung Ihres Teams im QMS- und Audit-Prozess. 4-stündiges Mock-Audit zur Bestätigung der Systembereitschaft und zur Sicherstellung der Zertifizierung. - [MRA Lösungsfinder

Priorisieren Sie nach Preis, Zeit und Einsicht.

](https://taoexcellence.ch/product/mra-solutions-finder/) - Herunterladbare Excel-Datei, mit der Sie die richtigen Lösungen für Ihr Unternehmen berechnen und priorisieren können. Eine endgültige Regulierungsstrategie, die nach Preis, Zeit und standortspezifischen Erkenntnissen priorisiert ist. 3-stündige Beratung, um die Nutzung dieses Tools zu optimieren und regulatorische Fragen zu beantworten. Klar definierte MRA / MDR-Szenarien mit den regulatorischen Anforderungen für jeden Bereich. Eine Checkliste aller Lösungen und die zu berücksichtigenden Schritte. Eingebaute Formel zur Berechnung der zuerst auszuführenden Aufgaben. Einblicke aus Ihrem Team in der Formel integriert, um Aufgaben zu priorisieren. - [MDR-Risikomanagement

Überprüfen Sie Ihre Risikomanagement.

](https://taoexcellence.ch/product/sop-checklist-tool/) - Excel-Datei zum Herunterladen die klar, detailliert und einfach zu bedienen ist. MDR und ISO 14971:2019 überprüfen Sie alle Anforderungen an Ihr Risikomanagement. Gap-Analyse-Tool erlaubt ein klares Verständin, wie konform Ihre SOPs gegenüber den Anforderungen des Risikomanagement sind Legen Sie einen Aktionsplan fest Verwenden Sie die Checkliste als Aktionsplam, um die Konformität zu gewährleisten. Überprüfen und verfolgen Sie Ihren Fortschritt anhand einer graphischen Übersicht über das Mass Ihrer Konformität. Bleiben Sie konform Verwenden Sie dieses Tool für Revisionen Ihrer SOPs und sichern Sie die Konformität. - [Select a Notified Body

Workshop on how to select a Notified Body.

](https://taoexcellence.ch/product/tactical-session-i/) - Interactive online workshop with deliverable actions to problem-solve and kickstart the process. Regulatory, strategic and market insight tailored to your company. Confirmed tactical strategy you can begin to implement the next day. In-depth knowledge designed to empower your strategic approach. Experienced specialists guiding you through the process. - [Contact a Notified Body

Workshop on finding and contacting a Notified Body.

](https://taoexcellence.ch/product/tactical-session-ii/) - Interactive online workshop with deliverable actions to problem-solve and kickstart the process. Regulatory, strategic and market insight tailored to your company. Confirmed tactical strategy you can begin to implement the next day. In-depth knowledge designed to empower your strategic approach. Experienced specialists guiding you through the process. - [Tactical Session III

How to collaborate with your Notified Body.

](https://taoexcellence.ch/product/tactical-session-iii/) - Interactive online workshop with deliverable actions to problem-solve and kickstart the process. Regulatory, strategic and market insight tailored to your company. Confirmed tactical strategy you can begin to implement the next day. In-depth knowledge designed to empower your strategic approach. Experienced specialists guiding you through the process. - [MDR Review

Prüfung der Konformität Ihre SOPs.

](https://taoexcellence.ch/product/mdr-review/) - Erhalten Sie eine Offerte Unfassende Prüfung stellt sicher, dass Ihre SOPs alle Anforderungen vollständig abdecken Sprachen wir prüfen Ihre Dokumente in Deutsch und Englisch. MDR Review Bericht als bearbeitbare Excel-Tabelle mit graphischer Darstellung Ihrer Konformität. Experten für RA und QA prüfen Ihre Dokumente und Arbeitsunterlagen. Angewandte Erfahrungen ermöglichen die kompetente Prüfung gemäss der MDR, ISO GCP, ISO 14971, PMS, QMS, ISO 13485, MDSAP, UDI, und weitere. - [MDR Clinical Practice

Check your clinical investigation compliance.

](https://taoexcellence.ch/product/mdr-clinical-practice/) - Downloadable excel file that is clear, accessible and easy-to-use. MDR and ISO 14155:2020 (GCP) compliance checklist of MDR requirements for clinical investigations. Gap analysis tool to show you how compliant your SOPs are against individual standards and MDR requirements for clinical investigations. Identify an action plan using the checklist of tasks to complete to achieve compliance Review and track SOP compliance with a % table summary measuring how complete the update is. Maintain 100% compliance by using this tool after your SOP updates to ensure continued compliance. - [DOE Kurs

Design Of Experiments mit Zertifikat.

](https://taoexcellence.ch/product/doe-course/) - pro Teilnehmer 1.5-tägiger DOE Kurs Lernen Sie, wie die Versuchsplanung mit DOE geplant, durchgeführt, analysiert und interpretiert wird. DOE Designs Erlangen Sie ein vertieftes Verständnis von Voll- , Teilfaktorieller Versuchsplanung. Anwendungsbeispiele für Medizinprodukte Üben Sie an tatsächlichen Beispielen aus Ihrem Arbeitsumfeld. Maximal 15 Kursteilnehmer Um eine fokusierte Lernumgebung zu erlauben. - [RA / QA Membership

Regulatory und Qualitätsmanagement.

](https://taoexcellence.ch/product/ra-qa-membership/) - Erhalten Sie eine Offerte Einfache Handhabung und Kostenkontrolle Greifen Sie unkompliziert auf die richtige Expertise und Erfahrung zu. Angewendete Unterstützung von gestandenen Experten Spezialisiert auf Medizinprodukte, Pharmaceutika und Kombinationsprodukte. Alle Themen rund um Regulatory Affairs und Qualitätsmanagement Gemäss ISO 9001, ISO 13485, MDR, IVDR, and MDSAP. Praktische Erfahrung, Kenntnisse und Anwendung Für ein erfolgreiches Audit, Zertifizierung und ein starkes QMS. Mentoring, Leitung und Schulungen Um Up-to-date und conform mit den Anforderungen zu bleiben. - [Post Market Surveillance

Gap analysis tool for PMS compliance.

](https://taoexcellence.ch/product/post-market-surveillance/) - Downloadable excel file that is clear, accessible and easy-to-use. Post-market surveillance (PMS) requirements all checked in one place. Gap analysis tool to show you how compliant your SOPs are against MDR requirements for PMS. Identify an action plan and use it to track activities and achieve compliance. Maintain an overview with a % table summary measuring your progress. Let team members know the exact requirements to address. - [Process Improvement 1

Level 1. Certified Six Sigma Yellow Belt Course.

](https://taoexcellence.ch/product/process-improvement-level-1/) - Price per person 2-day course using site-specific industry examples with printed course documents and meals provided. Ideal for non-conformance and CAPA projects to support ‘continuous improvement’ initiatives in your business. Full understanding of the DMAIC cycle with applicable tools for each phase. Apply specialised tools to your own case study to learn how to improve efficiency, reduce waste and manage your resources better. Specialised training with a certificate designed and lead by a Six Sigma Black Belt and medtech and pharma industry expert. - [Process Improvement 2

Level 2. Certified Six Sigma Green Belt Course.

](https://taoexcellence.ch/product/process-improvement-level-2/) - Price per person 9-day course in total over a 3-month period (each module takes between 1–3 days and includes a final exam). Project coaching included gives you the opportunity to run a live improvement project in parallel with the course’s content (awarded an additional certificate). Industry specific and highly structured with printed course documents and meals provided. Integrate the DMAIC cycle into your quality system using a highly technical and analytical approach that utilises our in-depth overview of all applicable methods. Ideal for leaders of improvement, non-conformance and CAPA projects and immediately applicable in your daily work. Apply advanced statistical tools and techniques to site-specific examples as well as your own live project. Learn how to continuously improve efficiency, reduce waste and enhance your team’s ability to communicate and collaborate. Specialised training with a certificate designed and lead by a Six Sigma Black Belt and medtech and pharma industry expert. - [IVDR Review

Support checking your SOPs against the IVDR.

](https://taoexcellence.ch/product/ivdr-review/) - Request a quote Complete service that will ensure your SOPs comply to the IVDR and standards you require. Checking bilingual documents in German and English. IVDR review report in an Excel document with clear visuals and compliance markers to track and review updates. Regulatory and quality management experts that will check the full scope of respective requirements. Experienced knowledge and latest insights into requirements for IVDR, ISO GCP, ISO 14971, PMS, QMS, ISO 13485, MDSAP, UDI, and more. - [MDR UDI

Gap analysis tool for UDI compliance.

](https://taoexcellence.ch/product/mdr-udi/) - Downloadable excel file that is clear, accessible and easy-to-use. Unique Device Identification (UDI) requirements all checked in one place. Gap analysis tool to show you how compliant your SOPs are against MDR requirements for UDI. Identify an action plan and use it to track activities and achieve compliance. Maintain an overview with a % table summary measuring your progress. Let team members know the exact requirements to address. - [EU-Konformitätserklärung (DoC)

Checkliste zur Prüfung der DoC.

](https://taoexcellence.ch/product/eu-konformitatserklarung/) - Download der Checkliste ermöglicht die sofortige Nutzung. MepV und MDR Konformität. Checkliste zur Überprüfung aller Komponenten der DoC. Unterscheidung notwendiger und optionaler Angaben. Grundlage für Übertragung in eigenes Qualitätsmanagementsystems. Dokumentation der DoC Überprüfung. - [EU-Konformitätserklärung (DoC)

Checkliste zur Prüfung der DoC.

](https://taoexcellence.ch/product/eu-konformitatserklarung/) - Download der Checkliste ermöglicht die sofortige Nutzung. MepV und MDR Konformität. Checkliste zur Überprüfung aller Komponenten der DoC. Unterscheidung notwendiger und optionaler Angaben. Grundlage für Übertragung in eigenes Qualitätsmanagementsystems. Dokumentation der DoC Überprüfung. - [IVDR-Risikomanagement

Überprüfen Sie Ihre Risikomanagement.

](https://taoexcellence.ch/product/ivdr-risk-management/) - Excel-Datei zum Herunterladen die klar, detailliert und einfach zu bedienen ist. IVDR und ISO 14971:2019 überprüfen Sie alle Anforderungen an Ihr Risikomanagement. Gap-Analyse-Tool erlaubt ein klares Verständnis, wie konform Ihre SOPs gegenüber den Anforderungen des Risikomanagement sind. Legen Sie einen Aktionsplan fest Verwenden Sie die Checkliste als Aktionsplan, um die Konformität zu gewährleisten. Überprüfen und verfolgen Sie Ihren Fortschritt anhand einer graphischen Übersicht über das Mass Ihrer Konformität. Bleiben Sie konform Verwenden Sie dieses Tool für Revisionen Ihrer SOPs und sichern Sie die Konformität. - [IVDR Risk Management

Gap analysis tool for risk management compliance.

](https://taoexcellence.ch/product/ivdr-risk-management/) - Downloadable excel file that is clear, accessible and easy-to-use. IVDR and ISO 14971:2019 compliance checklist of IVDR risk management requirements. Gap analysis tool to show you how compliant your SOPs are against individual RM standards and IVDR requirements. Identify an action plan using the checklist of tasks to complete to achieve compliance Review and track SOP compliance with a % table summary measuring how complete the update is. Maintain 100% compliance by using this tool after your SOP updates to ensure continued compliance. - [MDR Risk Management

Gap analysis tool for risk management compliance.

](https://taoexcellence.ch/product/sop-checklist-tool/) - Downloadable excel file that is clear, accessible and easy-to-use. MDR and ISO 14971:2019 compliance checklist of MDR risk management requirements. Gap analysis tool to show you how compliant your SOPs are against individual RM standards and MDR requirements. Identify an action plan using the checklist of tasks to complete to achieve compliance Review and track SOP compliance with a % table summary measuring how complete the update is. Maintain 100% compliance by using this tool after your SOP updates to ensure continued compliance. - [Select a Notified Body

Workshop on how to select a Notified Body.

](https://taoexcellence.ch/product/tactical-session-i/) - Interactive online workshop with deliverable actions to problem-solve and kickstart the process. Regulatory, strategic and market insight tailored to your company. Confirmed tactical strategy you can begin to implement the next day. In-depth knowledge designed to empower your strategic approach. Experienced specialists guiding you through the process. - [Contact a Notified Body

Workshop on finding and contacting a Notified Body.

](https://taoexcellence.ch/product/tactical-session-ii/) - Interactive online workshop with deliverable actions to problem-solve and kickstart the process. Regulatory, strategic and market insight tailored to your company. Confirmed tactical strategy you can begin to implement the next day. In-depth knowledge designed to empower your strategic approach. Experienced specialists guiding you through the process. - [Work with a Notified Body

Workshop on how to work with a Notified Body.

](https://taoexcellence.ch/product/tactical-session-iii/) - Interactive online workshop with deliverable actions to problem-solve and kickstart the process. Regulatory, strategic and market insight tailored to your company. Confirmed tactical strategy you can begin to implement the next day. In-depth knowledge designed to empower your strategic approach. Experienced specialists guiding you through the process. - [MDR Review

Support checking your SOPs against the MDR.

](https://taoexcellence.ch/product/mdr-review/) - Request a quote Complete service that will ensure your SOPs comply to the MDR and standards you require. Checking bilingual documents in German and English. MDR review report in an Excel document with clear visuals and compliance markers to track and review updates. Regulatory and quality management experts that will check the full scope of respective requirements. Experienced knowledge and latest insights into requirements for MDR, ISO GCP, ISO 14971, PMS, QMS, ISO 13485, MDSAP, UDI, and more. - [DOE Course

Learn to master design of experiments.

](https://taoexcellence.ch/product/doe-course/) - Price per person 1.5-day DOE course and certificate delivering applicable skills in planning, executing, analysing and interpreting design of experiments. DOE designs exploring full and partial factorial designs. Medical device and industry specific examples to gain a working knowledge of DOE. 15 people per course max to ensure a focused class environment. - [RA / QA Membership

Regulatory and quality management support.

](https://taoexcellence.ch/product/ra-qa-membership/) - Request a Quote Easy management and cost control giving you access to the right expertise as and when you need it. In-depth knowledge from proven experts specialising in medical devices, pharmaceuticals, and combination products. Complete regulatory and quality coverage including ISO 9001, ISO 13485, MDR, IVDR, and MDSAP. Practical advice, support and strategies for successful certification, audits and a strong QMS. Mentoring, leadership and training opportunities to optimise performance and maintain compliance and standards. - [Post Market Surveillance

Gap analysis tool for PMS compliance.

](https://taoexcellence.ch/product/post-market-surveillance/) - Downloadable excel file that is clear, accessible and easy-to-use. Post-market surveillance (PMS) requirements all checked in one place. Gap analysis tool to show you how compliant your SOPs are against MDR requirements for PMS. Identify an action plan and use it to track activities and achieve compliance. Maintain an overview with a % table summary measuring your progress. Let team members know the exact requirements to address. - [Process Improvement 1

Level 1. Certified Six Sigma Yellow Belt Course.

](https://taoexcellence.ch/product/process-improvement-level-1/) - Price per person 2-day course using site-specific industry examples with printed course documents and meals provided. Ideal for non-conformance and CAPA projects to support ‘continuous improvement’ initiatives in your business. Full understanding of the DMAIC cycle with applicable tools for each phase. Apply specialised tools to your own case study to learn how to improve efficiency, reduce waste and manage your resources better. Specialised training with a certificate designed and lead by a Six Sigma Black Belt and medtech and pharma industry expert. - [Process Improvement 2

Level 2. Certified Six Sigma Green Belt Course.

](https://taoexcellence.ch/product/process-improvement-level-2/) - Price per person 9-day course in total over a 3-month period (each module takes between 1–3 days and includes a final exam). Project coaching included gives you the opportunity to run a live improvement project in parallel with the course’s content (awarded an additional certificate). Industry specific and highly structured with printed course documents and meals provided. Integrate the DMAIC cycle into your quality system using a highly technical and analytical approach that utilises our in-depth overview of all applicable methods. Ideal for leaders of improvement, non-conformance and CAPA projects and immediately applicable in your daily work. Apply advanced statistical tools and techniques to site-specific examples as well as your own live project. Learn how to continuously improve efficiency, reduce waste and enhance your team’s ability to communicate and collaborate. Specialised training with a certificate designed and lead by a Six Sigma Black Belt and medtech and pharma industry expert. - [MDR UDI

Gap analysis tool for UDI compliance.

](https://taoexcellence.ch/product/mdr-udi/) - Downloadable excel file that is clear, accessible and easy-to-use. Unique Device Identification (UDI) requirements all checked in one place. Gap analysis tool to show you how compliant your SOPs are against MDR requirements for UDI. Identify an action plan and use it to track activities and achieve compliance. Maintain an overview with a % table summary measuring your progress. Let team members know the exact requirements to address. - [IVDR Review

Support checking your SOPs against the IVDR.

](https://taoexcellence.ch/product/ivdr-review/) - Request a quote Complete service that will ensure your SOPs comply to the IVDR and standards you require. Checking bilingual documents in German and English. IVDR review report in an Excel document with clear visuals and compliance markers to track and review updates. Regulatory and quality management experts that will check the full scope of respective requirements. Experienced knowledge and latest insights into requirements for IVDR, ISO GCP, ISO 14971, PMS, QMS, ISO 13485, MDSAP, UDI, and more. ## Courses - [Importer Training](https://taoexcellence.ch/course/importer-training/) - Enhance your expertise as a Swiss medical device importer with our comprehensive online course. Tailored specifically for Swiss importers, this course demystifies the regulatory landscape and delves deeply into the MedDO requirements, alongside relevant MDR references. ## Lessons - [5. Market Access](https://taoexcellence.ch/lesson/market-access/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [6. Quality Management System](https://taoexcellence.ch/lesson/quality-management-system/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [7. Storage and Transport](https://taoexcellence.ch/lesson/storage-and-transport/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [8. Traceability](https://taoexcellence.ch/lesson/traceability/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [9. Incident Management](https://taoexcellence.ch/lesson/incident-management/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [10. Article 16 of MDR / IVDR](https://taoexcellence.ch/lesson/article-16-of-mdr-ivdr/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [11. Transition Timelines](https://taoexcellence.ch/lesson/transition-timelines/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [3. Economic Operators](https://taoexcellence.ch/lesson/economic-operators/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [4. Regulatory Documents](https://taoexcellence.ch/lesson/regulatory-documents/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [2. Regulatory Landscape](https://taoexcellence.ch/lesson/regulatory-landscape/) - Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [12. Final Examination](https://taoexcellence.ch/lesson/final-examination/) - Welcome to the final examination for the Importer Training Course. This assessment will evaluate your understanding of key concepts and application of knowledge gained throughout the course. Good luck! Complete Lesson Take Quiz Completed Next Lesson Reset Lesson - [0. Introduction](https://taoexcellence.ch/lesson/introduction/) - Complete Lesson View Quiz Completed Next Lesson Reset Lesson - [1. Definitions](https://taoexcellence.ch/lesson/definitions/) - Complete Lesson View Quiz Completed Next Lesson Reset Lesson ## Quizzes - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination-2/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [12. Final Examination](https://taoexcellence.ch/quiz/12-final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - [Final Examination](https://taoexcellence.ch/quiz/final-examination/) - 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