Commercialization of medical devices and software

This module 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 module.

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 module a minor is 20 ECTS.

In this module, there are two mandatory courses:

• BMT-62237 Introduction to quality and regulation for medical product development
• BMT-62356 Product development of biomedical devices

You must choose 1 or 2 from the optional compulsory courses:

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

Additionally, you can choose from these complementary courses up to 20 credits:

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