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Medical Device Regulatory Affairs and Quality Assurance

MAS

sitem-insel AG

Universität Bern UNIBE

Categorie
Luogo di formazione

Berna 10 (BE)

Lingua di insegnamento

inglese

Tipo di formazione

Università e politecnici - Perfezionamento: formazioni lunghe

Modalità temporali

Parallelamente all'attività professionale

Ambiti

Diritto - Elettronica, microtecnica - Management, direzione - Salute, cure infermieristiche, medicina

Indirizzi di studio

Diritto - Gestione aziendale / economia aziendale - Medicina umana - Scienze e tecnologie biomediche - Tecnica medica

Swissdoc

7.555.33.0 - 7.724.4.0 - 7.616.35.0 - 7.623.3.0

Aggiornato il 09.11.2023

Descrizione

Descrizione della formazione

Regulatory specialists are integral to bringing novel medical devices to market. They require a breadth of managerial and interpersonal skills in addition to technical, clinical and legal knowledge. The program offers career specialised training for graduate students based on the newly implemented European Medical Device Regulations. In addition, the course provides participants with comprehensive knowledge and practical experience in: interna­tional RA, quality management, risk management, clinical evaluation of medical devices, technical writing and leadership. It addresses graduates interested in commencing a career in the regulation or quality control of medical devices. The program also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge of the regulation of medical devices.

Piano di formazione

The MAS Medical Device Regulatory Affairs and Quality Assurance consist of a minimum of 68 ECTS over a course duration of 24 months. Students complete compulsory modules and two elective modules chosen. The course includes a 12 month industry-based learning component during which the MAS thesis is completed.

Modules ECTS
Core Studies  
Research and Development Processes 2
EU Medical Device Regulations Part A 6
EU Medical Device Regulations Part A 6
EU Medical Device Regulations Part A 6
Quality Management 5
Risk Management and Usability Engineering 5
Advanced Studies  
Clinical Evaluation for Medical Devices 4
Digitalisation, Software and Cybersecurity 3
International Regulatory Affairs 3
Elective Studies  
Combination Products 3
Market Access and Pricing 2
Leadership, Team and Project Management for Regulatory Experts 2
Master Thesis 16

Ammissione

Condizioni d'ammissione

Participants must hold a Bachelor or higher degree in life science, medicine, engineering science, natural sciences, law or equivalent

Zielpublikum

The program addresses university graduates interested in commencing a career in the regulation or quality control of medical devices. The program prepares stu­dents to work as a regulatory officer or quality manager within a medical device company or regulatory body. The program also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge of the regulation of medical devices according to the new European MDR.

Iscrizione

Mitte August

Costi

CHF 31'500.-

Diploma

  • Master of Advanced Studies MAS

Master of Advanced Studies in Medical Device Regulatory Affairs and Quality Assurance MDRAQA University of Bern

Informazioni pratiche

Luogo / indirizzo

  • Berna 10 (BE)

sitem-insel School, Freiburgstrasse 3, 3010 Bern

Svolgimento temporale

Inizio

September

Durata

2 years

Modalità temporali

  • Parallelamente all'attività professionale

Lingua di insegnamento

  • inglese

Link

Informazioni / contatto

Mark Illi, Managing Co-Director
E-Mail: school.sitem@unibe.ch

orientamento.ch