The CARAQA is the certified full curriculum for preparing Regulatory, Clinical and Quality experts in the MedTech world.
During the CARAQA training you will be able to meet your professional development needs on both EU and US regulations. Hence, you will learn how to perform a smooth transition to the new requirements under MDR / IVDR as well as the one US FDA.
A good balance between theory and hands-on practice is present in the program. As a result, the CARAQA is an on-the-job training!
The CARAQA training provide a high level preparation to match the competences required by the MedTech Industry.
Article 15 of the MDR/IVDR requires that manufacturer and authorized representative identify a person responsible for regulatory compliance (PRRC). The CARAQA training program is delivered by state accredited engineering schools, therefor the CARAQA program allows students to fulfils the requirements of Article 15 related to PRRC.
The CARAQA training is structured in three main pillars: Clinical Affairs, Regulatory Affairs and Quality Assurance – CA/RA/QA.
Choose your CARAQACARAQA programs are currently running in Switzerland and Belgium. Hurry up and register for the next session!
School of Life Sciences FHNW
Basel Muttenz, Switzerland
12 January 2021
Additional programs are in preparation in Lübeck DE, Copenhagen DK and Philadelphia (PA-US).
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Meet the CARAQA Alumni
Every speaker was inspiring, full of knowledge and experience. I enjoyed the trainers’ personal comments about their experiences in the industry in relation with the training’s content. The presentations included good pratical case studies.
It was for me an optimal preparation to face the new challenges of the upcoming IVDR.
Taking part to the CAS-CARAQA program helped me dive deep in the complex MedTech regulatory field and gain confidence as a RAQA professional.
The program, well designed to address a wide audience from medical devices and in-vitro diagnostic companies, superbly integrates diverse learning tools, from class lecture to hands-on sessions and talks from regulatory and Industry experts, with case scenarios shaped to reflect both start-ups and corporate realities. The great mosaic of notions is finely balanced with sharing of professional experiences and real-life cases by the highly skilled trainers.
I am absolutely enthusiastic about this program and recommend it to both aspiring and experienced CA/RA/QA professionals, as well as to CEOs.
That was a pleasure participating in the CARAQA program. We came from different angles of the industry with different experiences and gained a common solid knowledge about the recent changes in the Medical Device, In vitro Diagnostics Industry. The program is built up with clusters, the clusters are linked, cross referenced, so we have got familiar with this complex system in a practical manner through case studies and challenging discussions. I am happy and also proud that I completed the CARAQA.
Meet the CARAQA managing team
The CARAQA academic team includes the three professors of HEIG-VD in Yverdon-Les-Bains, School of Life Sciences FHNW in Basel-Muttenz, UCLouvain in Louvain-La-Neuve, together with Dr. Elena Lucano and Philippe Etter from Medidee