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Regulatory Affairs in Life Science

CAS

Haute école spécialisée bernoise (HESB)

Categorie
Luogo di formazione

Biel/Bienne (BE)

Lingua di insegnamento

inglese

Tipo di formazione

Perfezionamento: formazioni lunghe - Scuole universitarie professionali SUP

Modalità temporali

Tempo parziale

Ambiti

Elettronica, microtecnica

Indirizzi di studio

Scienze e tecnologie biomediche - Tecnica medica

Swissdoc

7.555.33.0

Aggiornato il 06.08.2025

Descrizione

Descrizione della formazione

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)

Ammissione

Condizioni d'ammissione

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.

Link verso l'ammissione

Iscrizione

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

Costi

CHF 7'500.-

Diploma

  • Certificate of Advanced Studies CAS

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

Informazioni pratiche

Luogo / indirizzo

  • Biel/Bienne (BE)

Berner Fachhochschule
Aarbergstrasse 46
2503 Biel

Svolgimento temporale

Inizio

Autumn

Durata

Week 43 to week 14

Modalità temporali

  • Tempo parziale

Lingua di insegnamento

  • inglese

Link

Informazioni / contatto

Berner Fachhochschule Technik und Informatik
Weiterbildung

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

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