Commercialization of medical devices and software
This minor will be offered through FITech for the last time in the academic year 2021-2022. Please also note that the application deadline for courses belonging to a minor that are offered in the spring semester is exceptionally already on November 1st. Please check the individual courses for updates regarding future availability.
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 completing this minor is 20 ECTS.
It is recommend to take the courses in the following order:
In this module, there are two mandatory courses:
- BBT.MJS.142 Introduction to quality and regulation for medical product development
- BBT.MJS.146 Product development of biomedical devices
You must choose 1 or 2 from the optional compulsory courses:
- BBT.MJS.143 Regulatory requirements for design and manufacture of medical devices
- BBT.MJS.144 Standards, interoperability and regulations in health informatics
Additionally, you can choose from these complementary courses up to 20 credits:
- BBT.MJS.147 Health technology and life science R&D
- BBT.MJS.141 Health technology and life science business