Medical regulatory words: compliance, standards, policies and regulations
Continuing Education

Health technology solutions – product development and commercialization

This study module gives you extensive and comprehensive knowledge how to design, manufacture and place on the market health technology products to the global healthcare market, as well as related regulations, requirements and standards.

The study module includes 2 compulsory courses and 2 optional courses of which you may choose only 1. Each course is worth 5 ECTS. 

Begin with an introductory course (autumn 2021):

Introduction to quality and regulation for medical product development (5 ECTS)

Deepen your skills with one of the optional courses (spring 2022):

  1. Standards, interoperability and regulation in health informatics (5 ECTS)
  2. Regulatory requirements for design and manufacture of medical devices (5 ECTS)

Complete your studies with final course (autumn 2022):

Product development of biomedical devices (5 ECTS)

All courses can be carried out also separately.

Target group

This study module is targeted for those who are working or willing to work in R&D and/or quality and regulatory roles in health technology companies. The module gives essential knowledge about product development and regulatory affairs also for health technology start-ups.

For those who would like to have a competence to be “Person responsible for regulatory compliance” this study module offers a formal additional education when you already have a university degree in law, medicine, pharmacy, engineering or another relevant scientific discipline or 4 years of professional experience in regulatory affairs or in quality management systems on medical devices.

Saara Hassinen, CEO of Healthtech Finland

“As for the implementation of the regulations, there are concerns over the availability of the required skills. After the regulations take effect, manufacturing companies will have to appoint someone to oversee compliance, and this person will also have significant responsibilities relating to quality management.”

Here you can find all the courses and this study module