

Introduction to quality and regulation for medical product development
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The course introduces the key concepts and definitions in the field and the stages of product development and product life cycle. Versatile product testing, product safety verification and related standards and requirements will be introduced.
You can complete the course by participating in multimodal teaching or online teaching. Multimodal teaching is held 2 h / 2 times a week.
Targer group
This course 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 course gives essential knowledge about product development and regulatory affairs also for health technology start-ups.
“This is an excellent opportunity for companies to support the development of expertise among their staff,” says Saara Hassinen, CEO of Healthtech Finland.
This course is part of Health technology solutions – product development and commercialization (programme). Get acquainted with the programme and other courses included in it.
The programme offers a formal additional education for a “Person responsible for regulatory compliance” required by the new EU regulations in Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR).
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Here are all the courses and the programme mentioned previously
Introduction to quality and regulation for medical product development
Study module - non degreeContent ownerTampere UniversityHealth technology solutions – product development and commercialization (programme)
Study module - non degreeContent ownerTampere UniversityProduct development of biomedical devices
Study module - non degreeContent ownerTampere UniversityRegulatory requirements for design and manufacture of medical devices
Study module - non degreeContent ownerTampere UniversityStandards, interoperability and regulation in health informatics
Study module - non degreeContent ownerTampere University