Description de la formation

CAS: Certificate of Advanced Studies (CAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 10 ECTS.

The European market for medical devices and in-vitro diagnostics, the second largest such market in the world, is undergoing a significant evolution with the implementation of the new Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostics Regulation (EU 2017/746). Compared to the EU Directives, the Regulations have expanded the requirements for achieving a high level of medical device safety and performance in Europe. To satisfy these requirements, the demand for regulatory, quality and clinical affairs professionals throughout Europe has increased significantly. In addition, medical device and in vitro diagnostics manufacturers located in Switzerland face even more challenges. Due to the outdated Mutual Recognition Agreement, Swiss companies are in effect from a third party country when entering the European market, creating additional burdens. Meanwhile, countries in the Gulf, Asia and South America have introduced requirements that are at least as complex as those in Europe or the US. As a result, exporting to all these regions is a major challenge for Swiss firms.

This programme is designed for regulatory, clinical and quality professionals in the European medical devices and in vitro diagnostics sectors. Our education programme provides participants with advanced knowledge, hands-on experience and first-hand skills from industry experts. The structure of the programme enables participants to assume responsibility within their organisation for regulatory compliance (PRRC) in accordance with Art. 15 MDR and IVDR. This will enable professionals to make key organisational decisions and play a vital role in maintaining the competitiveness and longevity of the business. The programme provides an in-depth insight into regulatory, clinical and quality management issues and emphasises the application of this knowledge in a practical professional context.

CAS CARAQA in Muttenz is part of the European CARAQA network. To date, more than 190 participants have successfully completed CARAQA in Muttenz, Yverdon-Les-Bains, Lubeck and Louvain-La-Neuve in Belgium.

The CAS CARAQA develops the following skills:

• Optimal preparation for regulation according to MDR 2017/745 and IVDR 2017/746
• Strategic planning and management of clinical evaluations, investigations in accordance with ISO 14155 and performance studies of IVDs
• Strategic and tactical communications for interaction with Notified Bodies and National Competent Authorities, as well as crisis management
• Management and technical support for new product development projects
• Leadership in implementing and maintaining ISO 13485 and US QSR quality management systems
• Structuring of supply chain, production and marketing

Technical expertise in key subjects such as risk management, biocompatibility, usability and software validation, according to current standards

Plan de la formation

13 ECTS-Punkte

1 ECTS-Kreditpunkt entspricht einem Arbeitsaufwand von 25 bis 30 Arbeitsstunden.

Program Structure

The CARAQA training is structured around three areas: Clinical Affairs, Regulatory Affairs and Quality Assurance - CA/RA/QA. Understanding and connecting these is essential for professionals in the field. As this landscape is still very dynamic and the requirements set by the European Commission are constantly evolving, the content of the program will be continuously adapted to reflect the current needs and challenges of the medical device and in vitro diagnostics industry.

• Introduction to the world of Medical Devices and In-Vitro Diagnostics
• Course 1: Regulatory Affairs
• Course 2: Quality Management
• Course 3: Clinical Affairs