The Tao of Excellence
Specialist consultants for the medical devices industry, with a team of experts based in Switzerland that can support your regulatory strategy with the MDR (Medical Device Regulation) and IVDR (In Vitro Device Regulation) in Europe and MDSAP (Medical Device Single Audit Program) regions. Services in Quality Management System (QMS/eQMS), Six Sigma training, Gap Analysis, Clinical Evaluation Reports, compliance, certification, audit readiness, data analysis, business intelligence, digitalization, agile business development, specialist market insight and business training. Contact us to optimise your business processes and procedures and secure your compliance for the medical device regulations.
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Why us?
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Solution-oriented, Flexible and Positive
We do honest, straight-to-the point and relevant work. Our ethical values are the core of our daily activities and inspire an open, efficient and respectful environment.
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Creative, innovative and Process-knowledgeable
We find ideal solutions by inviting out-of-the box ideas and leveraging from long-term experience of approaches that actually work in practice.
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Customer Focused
We take your personal objectives as the basis to define our success.
“…they were patient and very present and had the ability to focus on the essential and settle quickly into our team… they got straight into the relevant issues, assessed where we actually were and from there took a step by step approach to reach our goal.”
—Employees, SMEs
Meet us
Our team of specialists, based in Switzerland, has the best expertise to support and enable your business to reach its regulatory and commercial success and assist your organisation in its certification process to access to the medical devices market. We are passionate and knowledgeable about what we do, and we have the agility to rapidly adapt our services to your business requirements and wider changes in the market, providing productive and cost-effective solutions.
Management
Jasminka Roth CEO
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.
We are a team of highly dedicated and openminded experts.
We operate within an international network particularly strong in the medical device combination products and pharma industry.
Get in Touch
We are looking forward to meeting you and discussing your questions.