Clinical Affairs, Regulatory and Quality

for Medical Devices and In-Vitro Diagnostic


The adoption of the new European regulation on medical devices and in vitro diagnostic requires serious adaptations in the Medtech sector, and most notably the involvement of a "Qualified Person” within the company itself. These changes result in major pressure on the employees in charge of activities including Clinical Affairs, Regulatory Affairs and Quality Assurance. Countries in the Gulf, Asia and South America now have requirements that are as complex as those in Europe or the USA. Exporting to these countries is therefore a challenge for Swiss firms. The CAS-Program fulfils the requirements of article 15 of MDR / IVDR.

The Training involves the development of a wide range of technical and human skills to become the company's decision-making centres and play a key role in maintaining the company's competitiveness and sustainability in the face of development.

This includes optimal preparation for regulatory changes with MDR 2017/745 and IVDR 2017/746, strategic, tactical and communication skills in crisis situations and interaction difficulties with Notified Bodies and authorities, management skills around production and marketing processes for new medical devices, technical expertise in key issues such as biocompatibility, usability, clinical testing and evaluation, software validation, management support in new product development.

Target Audience

  • Employees in the regulatory, clinical and / or quality assurance department

  • Engineers from electronics, mechanical or software disciplines, in charge of medical device or in-vitro medical device projects

  • Experts in manufacturing and production

  • Physicians, scientists or inventors of medical products

  • Laboratory assistants involved in the development of new analytical methods or process automation

  • Employees involved in clinical studies or quality/ regulatory processes in a healthcare organization

HEIG-VD, Yverdon-les-Bains

  • Next start: September 2019

  • Duration: 28 days of courses over 7 months 

  • Final application date: August 2019

  • School day: Friday


Additional information


FHNW Campus Muttenz

  • Next start: 7 January 2020

  • Duration: 26 days over 6 months

  • Final application date: 3 November 2019

  • School day: Tuesday


Additional information



Additional information

Swiss Medtech

Swiss Medical Technology Association

Freiburgstrasse 3
3010 Berne


Member of:

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