Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostic
Haute école spécialisée de Suisse occidentale HES-SO
Description de la formation
The CAS contributes to the development of skills including:
- Optimal preparation in the new regulatory environment of the MDR 2017/745 and the IVDR 2017/746
- Strategic, tactical and communications aptitude faced with crisis situations and interaction difficulties with Notified Bodies and the Authorities
- Managerial capabilities surrounding production and marketing processes for new medical products
- Technical expertise in key subjects such as biocompatibility, usability, clinical investigation and evaluation, software validation
- Management support during the development projects for new products
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 is made of four modules :
- Introduction to world of devices
- Regulatory affairs, design and submissions
- Quality Management
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.
- Higher education degree such as a Bachelor or Master’s degree, of the type HES or EPF / UNI or equivalent, in the following fields:
- Engineering, chemistry, biology or life science
- Graduate in management or corporate economics
- Higher education in nursing, radiology or physiotherapy
- Admission by application possible for holders of ET or CFC level education in a suitable educational domain (physical or chemical laboratory assistant) with extensive professional experience
- As the instruction and educational materials are provided in English, proficiency in English (reading and writing) is a prerequisite
- Employee within the regulatory, clinical and/or quality department of a manufacturing or subcontracting company
- Specialist involved in the manufacturing of sensitive medical products
- Laboratory assistant involved in the development of new analytical methods or process automation
- Mechanical, electronic or software engineer in charge of medical devices or IVD development projects
- Physician, scientist or inventor of medical products
- Employee involved in clinical studies or quality / regulatory processes within a healthcare organization
- Certificate of Advanced Studies CAS
Certificate of Advanced Studies (CAS) HES-SO in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostic (CAS CARAQA)
Lieu / adresse
- Yverdon-les-Bains (VD)
Début des cours
Durée de la formation
28 days of courses over 7 months (including final exam), class every Friday.
- À temps partiel
This training is offered in partnership with Medidee Services SA, an international partner involved in clinical, regulatory and quality affairs for Medical Devices and IVD.
Renseignements / contact
Didier Maillefer, Tél. 024 557 64 14, firstname.lastname@example.org