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Martin Schmid

Senior Consultant & Managing Director

en.co.tec Schmid KG - Consulting & Academy for medical devices and IVD

Vienna, Austria

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Consultant, auditor, trainer, expert in the medical technology sector - Regulatory affairs, quality management and approvals - Focus EUR, USA, ISO13485, MDSAP

My organisation

At en.co.tec you can expect individual support and customized advice: Implementation and auditing of quality management systems at manufacturers and suppliers,, Support with regulatory affairs and compliance with all relevant standards and regulations for medical devices,, risk management & many other standards, and, Online-courses and inhouse-trainings on current topics - such as the EU regulations for medical devices & IVDs, digital health, cybersecurity, EU-AI-Act and many more.
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About me

Education / experience

Studied electrical engineering and has many years of industrial experience in the medical technology sector as Head of Technology and Quality Manager, Managing Director of en.co.tec KG since 2000.

For many years trainer and consulting expert at en.co.tec and lecturer at universities and technical colleges and co-designer of postgraduate academic courses.

Co-initiator of innovative offers for the medical device community such as the Expert Consultation Hour and the Online Forum in cooperation with Austrian and German life science clusters and co-organizer of the Austrian Regulatory Conference.

For more than 30 years, he has been supporting a wide range of medical device and IVD companies with the introduction and audits of quality management systems and accompanying medical device approvals.

Areas of work

Regulatory Affairs according to the EU regulations MDR/IVDR and quality management systems especially for manufacturers and suppliers of medical devices (focus on active medical devices and software as well as material medical devices) and in-vitro diagnostics. Regulations and standards: EU regulations MDR/IVDR, ISO 13485, MDSAP, ISO 14971, IEC 62304.

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Speaker sessions (1)

Wednesday, 15 October 2025

10:40 - 11:00

MDR and IVDR Update

Location:Room 1: Maria Theresia