Solutions & Products

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 has the specialist expertise to support your business development for the future.

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Hygiene Measures

Level 1: Sounding board consultation service.

FREE 

Establishing a clear and effective hygiene strategy for procedures in your office or working environment will be vital to protecting the health and safety of your teams and business during the threat of COVID-19. We are offering a free consultation service with a process design and hygiene expert specialising in the field of medical devices and healthcare to talk through your proposed hygiene procedures and ensure they are optimized for your business.

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Hygiene Measures

Level 2: Developing your approach and logistics.

600 CHF plus VAT

An in-depth assessment of your hygiene procedures and the development of a strong hygiene strategy to help mitigate against the risk of COVID-19 as restrictions begin to lift and people return to work. Our process design and hygiene experts will guide you through the concept stage and logistics of strengthening your hygiene strategy, including a 2-hour consultation, a downloadable checklist designed in line with government guidelines and hygiene standards, and a 1-hour coaching and follow-up session to confirm your approach and implementation plan.

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Hygiene Measures

Level 3: Optimise your hygiene set-up.

1’900 CHF plus VAT

This service will provide an in-depth assessment of your current hygiene measures and produce a comprehensive, practical and effective hygiene concept tailored to your business and implemented with support and training. A process design and hygiene expert specialising in medical device and healthcare industries will work with you to review, develop and improve your hygiene procedures to secure the safe and practicle working environment for your teams. Protecting against the risk of COVID-19 as restrictions begin to relax and businesses restart. Alongside checking the efficacy and efficiency of each measure and producing a new hygiene procedures document and implementation strategy, our experts will provide training and customised hand-outs for your team to ensure a clear and concise picture of all hygiene procedures and how to operate within your business.

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MRA Solutions Finder

Prioritise tasks by price, time and insight.

600 CHF plus VAT

Medical device manufacturers in Switzerland must now prepare to face ‘third country’ requirements in the EU. This downloadable excel tool will calculate costs and prioritise tasks to find the right solutions for your business and includes a 3-hour consultation with a regulatory specialist.

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ISO 13485 Starter Kit

The QMS for your medical device.

4’150 CHF plus VAT

Designed to support start-ups. This package is the fastest and most direct route to building an effective and efficient quality management system (QMS) that will meet regulatory requirements and ensure your QMS is compliant with ISO 13485 certification. For clients accessing the European market we will integrate QMS requirements under the EU’s MDR / IVDR free of charge.

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ISO 9001 Starter Kit

Certification in 8 weeks.

3’400 CHF plus VAT

Streamline your QMS and secure ISO 9001 certification in just 8 weeks. This program analyses your QMS to make your processes and procedures not only ISO 9001 compliant, but also more efficient and agile so that your business can adapt to any regulatory or market changes.

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MDR Risk Management

Check and track your risk management compliance.

175 CHF plus VAT

This downloadable excel document is built for quality, regulatory and process owner teams to ensure that your standard operating procedures (SOP) comply with the risk management (RM) requirements set out in the MDR (EU) 2017/745 and defined by ISO 14971:2019. Designed as a unified, clear and easy-to-use document, this tool performs a gap analysis of the tasks you need to complete to comply with the MDR risk management requirements. It is also a review and progress report you can use after your updates to ensure that your SOP continues to maintain 100% compliance.

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Tactical Session I

How to select your Notified Body.

200 CHF plus VAT

Finding the right Notified Body (NB) for your company is the first step to ensuring your certification process runs as smoothly, efficiently and as quickly as possible. NBs designated under The EU’s MDR are in short supply. It is therefore crucial, particularly for SMEs, to ask the right questions now to create a strategic approach that will identify which NB will deliver what your company needs. This 2-hour, interactive, online workshop is designed to give you the regulatory and strategic insight you need to ensure your certification process starts off on a strong foundation.

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Tactical Session II

How to contact your Notified Body.

200 CHF plus VAT

Once selected it is strongly advised that companies have a good strategy in place for how they will approach, contact and connect with a Notified Body (NB). MDR designated NBs are still in short supply so manufacturers, especially SMEs, need to take the appropriate steps now to ensure their certification is not delayed by the restricted capacity of NBs that are available. This 2-hour, interactive, online workshop is designed to give you the regulatory and strategic insight you need to secure your preferred NB and ensure the fastest certification process possible.

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Tactical Session III

How to collaborate with your Notified Body.

200 CHF plus VAT

Establishing good communication and collaboration between you and your Notified Body (NB) is the key to a quick and smooth certification process. It also lays the foundations for your on-going relationship. Our experienced specialists will guide you through the best strategies, methods and practices that will ensure your communication and collaboration is both efficient and productive, as well as tailored to your company’s needs. This 2-hour, interactive, online workshop is designed to give you the regulatory and strategic insight you need to implement the right practices for your business, speed up your certification process and establish the best possible working relationship with your chosen NB.

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