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Regulatory Affairs in Life Science

CAS

Haute école spécialisée bernoise (HESB)

Catégories
Lieu de formation

Biel/Bienne (BE)

Langue d'enseignement

anglais

Type de formation

Formation continue: formations longues - Hautes écoles spécialisées HES

Modalités temporelles

À temps partiel

Thèmes de formation

Électronique, microtechnique

Filières d'études

Sciences et technologie biomédicales - Technique médicale

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Mise à jour 06.08.2025

Description

Description de la formation

Certificate of Advanced Studies is a postgraduate qualification awarded by universities and corresponds to at least 10 ECTS (credit points).

Products from the life sciences industry are subject to strict national and international laws and standards. The CAS Regulatory Affairs in Life Sciences focuses on the regulations concerning medical devices, in vitro diagnostics, and medical software. Experienced experts will guide you through the practice-oriented course content and equip you with the necessary knowledge to navigate the regulated environment of the life sciences industry.

  • Overview Regulations
  • Regulatory requirements for medical devices in the USA
  • Quality and risk management
  • Product Engineering
  • Validation and Operation
  • Digitalization and cybersecurity in life sciences
  • Semester project (Living Case)

Admission

Conditions d’admission

As a rule, a university degree and practical experience are required for admission. 
People with a high vocational training can apply, provided they have suitable professional experience and prior scientific and methodological knowledge. 

Ideally, students possess a degree in engineering, medical technology, or medical informatics, in medicine/veterinary medicine, in pharmacy or in life sciences.

Target audience

Participants:

  • are planning to work in a regulated environment in the medical device- or in the life sciences industry.
  • are currently working in the areas of development, manufacturing, quality management or regulatory affairs.
  •  are responsible for the early detection and analysis of risks in the areas of medical technology, medical informatics or in the life sciences industry.

Lien sur l'admission

Inscription

See the provider's website. Registration takes place online.

Coûts

CHF 7'500.-

Diplôme

  • Certificate of Advanced Studies CAS

Certificate of Advanced Studies (CAS) in «Regulatory Affairs in Life Sciences»

Infos pratiques

Lieu / adresse

  • Biel/Bienne (BE)

Berner Fachhochschule
Aarbergstrasse 46
2503 Biel

Déroulement temporel

Début des cours

Autumn

Durée de la formation

Week 43 to week 14

Modalités temporelles

  • À temps partiel

Langue d’enseignement

  • anglais

Liens

Renseignements / contact

Berner Fachhochschule Technik und Informatik
Weiterbildung

Tel. +41 (0)31 848 31 11
E-Mail: office.ti-be@bfh.ch

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