The CAS CARAQA is a postgraduate continuing education program proposed by HEIG-VD in association with Veranex.

The program of the CAS is structured to cover the main requirements of Regulatory Affairs, Clinical Affairs and Quality Assurance applied to Medical devices (MD) and In Vitro Diagnostic devices (IVD) along the product lifecycle: Design - Production - Market Introduction.

The content of the course covers the recent adoption of the new european regulation on Medical Devices (MDR) and In Vitro Diagnostic (IVDR), in particular the requirement for a "qualified person".

The course is segmented in 3 modules:

CA: Clinical Affairs: obtain the right to conduct a clinical investigation demonstrating safety and/or efficacy. Also, maintain this demonstration (Clinical Evaluation Report) using literature and other post market information

RA: Regulatory Affairs: master the strategic, tactical and technical aspects to meet legal requirements in order to introduce products on the market

QA: Quality Assurance: implement and maintain the systems required to design and manufacture and a safe and effective product

A CAS thesis study conducted by each participant on an individual subject will cover the complete scope of the course content.