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Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostic

CAS

Haute école spécialisée de Suisse occidentale HES-SO > Haute école d'ingénierie et de gestion du canton de Vaud (HEIG-VD)

Catégories
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

Sciences et technologie biomédicales - Technique médicale

Swissdoc

7.555.33.0

Mise à jour 31.05.2022

Description

Description de la formation

Objectifs

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)

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

orientation.ch