Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostic
CAS
Haute école spécialisée de Suisse occidentale HES-SO
- Lieu de formation
-
Yverdon-les-Bains (VD)
- Langue d'enseignement
-
anglais
- Type de formation
-
Hautes écoles spécialisées HES - Formation continue: formations longues
- Modalités temporelles
-
À temps partiel
- Thèmes de formation
-
Électronique, microtechnique
- Domaines d'études
- Swissdoc
-
7.555.33.0
Mise à jour 25.04.2023
Description
Description de la formation
Objectives
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
- Clinical
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.
Admission
Conditions d’admission
- 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
Target audience
- 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
Coûts
CHF 7'000.-
Diplôme
- 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)
Infos pratiques
Lieu / adresse
- Yverdon-les-Bains (VD)
Centre St-Roch
Déroulement temporel
Début des cours
September
Durée de la formation
28 days of courses over 7 months (including final exam), class every Friday.
Modalités temporelles
- À temps partiel
Langue d’enseignement
- anglais
Remarques
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.
Liens
Renseignements / contact
Didier Maillefer : Tél. 024 557 64 14, didier.maillefer@heig-vd.ch
Institution 1
Haute école spécialisée de Suisse occidentale HES-SO
Route de Moutier 14
2800 Delémont
Tél.: +41 (0)58 900 00 00
E-mail:
URL:
www.hes-so.ch/
Autres informations
Haute école d'ingénierie et de gestion du canton de Vaud (HEIG-VD)
Haute école spécialisée de Suisse occidentale (HES-SO)
Rte de Cheseaux 1
1401 Yverdon-les-Bains
Tél.: +41 (0)24 557 63 30
E-mail:
URL:
www.heig-vd.ch/
Autres informations