CARAQA is a full curriculum for preparing Regulatory, Clinical and Quality experts for the implementation under MDR / IVDR. It fulfils the requirements of Article 15 related to PRRC because the certificate is delivered by state accredited engineering schools in Switzerland and Belgium.

The program has been designed to integrate a good balance of theory and hands-on practice.

CARAQA is an on-the-job training, one day per week and includes a personal thesis. CARAQA can be attended in:

  • HEIG-VD | Yverdon-les-Bains, Switzerland
  • FHNW | Muttenz, Switerland
  • UCLouvain | Louvain-la-Neuve, Belgium
  • Technische Hochschule Lübeck | Lübeck, Germany

Two additional programs are in preparation in Copenhagen DK and Philadelphia (PA, USA).

To get regular updates, please follow the LinkedIn CARAQA site

The CARAQA training programs are similar and provide a high-level preparation to match the competencies required by the MedTech Industry and by the article 15 of MDR/IVDR “Person responsible for regulatory compliance”.

For more information, please contact schools above or the Medidee’s CAS coordinator