
Health technology solutions – product development and commercialization (programme)
Extent
15 ECTSCourse dates
Application period
Fees
Language of instruction
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Organising unit
Mode of study
Study level
Health technology products are tightly regulated and controlled by the authorities. Up-to-date information on regulations, requirements and industry practices are the keys to successful product development and product commercialization. This program offers you the opportunity to expand your knowledge and grow as an expert in health and medical technology.
The program includes four courses. Two of them are compulsory and two are optional of which you may choose one. If completing the program is not currently relevant to you, you can also take individual courses as needed.
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):
- Standards, interoperability and regulation in health informatics (5 ECTS)
- 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 programme 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 programme 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.
Introduction to quality and regulation for medical product development
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OPTION 1: Standards, interoperability and regulation in health informatics
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OPTION 2: Regulatory requirements for design and manufacture of medical devices
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Product development of biomedical devices
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Feedback and experiences from the programme
Regulatory training is necessary already at the R&D stage
PhD Mikael Turunen works at Algoa Progress which develops software for modelling the progression of osteoarthritis: “Although we are not manufacturing an actual device, our software counts as one. Everything that affects the treatment of patients falls within the scope of medical device regulations. It was important to bring regulatory expertise on board at this point."


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.”