Commercialization of medical devices and software

This minor prepares the student for the commercialisation of health technology products including fulfilling the regulatory requirements.

In commercialisation process, the standards and regulations in different markets such as USA, EU, China and Japan need to be taken into account – from the research phase to marketing and after sales services. Thus, anyone who is interested to be part of any kind of company in biomedical productisation will benefit from this minor.

Moreover, a new EU regulation requires all companies to have a “Person responsible for regulatory compliance”. This module offers a formal education for this profession. After this, the person has to do work based training to get the approval to work as a regulatory compliance person.

Required minimum amount of ECTS for making this minor is 20 ECTS.

It is recommend to take the courses in the following order:

Begin the minor with a mandatory introductory course:

• BMT-62237 Introduction to quality and regulation for medical product development

Deepen your skills with at least one of the optional compulsory courses:

• BMT-62107 Regulatory requirements for design and manufacture of medical devices
• BMT-57408 Standards, interoperability and regulation in health informatics

Complete the minor with optional courses:

• BMT-86106 Health technology and life science business
• BMT-86006 Health technology and life science R&D

Complete your studies with another mandatory course:

• BMT-62356 Product development of biomedical devices