Description de la formation

The program provides a high-level preparation to match the competences required by the MedTech Industry, including the requirement to identify a person responsible for regulatory compliance (PRRC).

The CAS develops the following skills:

• Optimal preparation for MDR 2017/745 and IVDR 2017/746 regulatory changes
• Strategic planning and management of clinical evaluations, investigations under ISO 14155 and IVD performance studies
• Strategic and tactical communication for interaction with Notified Bodies and National Competent Authorities and to deal with crisis situations
• Management and engineering support during new product development projects
• Leadership in the deployment and maintenance of Quality Management Systems under ISO 13485 and US QSR
• Structuring of supply chain, production and marketing structuring
• Technical expertise in key subjects such as risk management, biocompatibility, usability, and software validation, according to current standards

The CAS earns 12 ECTS credits.

Le Certificate of Advanced Studies (CAS) est une formation postgrade donnée par les hautes écoles et équivaut à au moins 10 crédits ECTS.

1 crédit ECTS correspond à environ 25-30 heures de travail.

Plan de la formation

This CAS consists of three modules and a personal project:

• Introduction to world of devices
• Regulatory affairs, design and submissions
• Quality Management
• Clinical

The completion of the program will be accompanied by the writing of an extensive individual thesis. The subject of the thesis is a complete RA, CA & QA study of a medical device or IVD device along the 4 modules of the program. The device can be individually decided by each participant, possibly linked to his/her professional activity.