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Medical regulatory words: compliance, standards, policies and regulations

Health technology solutions – product development and commercialization (programme)

Tampere University

Extent

15 ECTS

Course dates

30.8.2021-31.12.2022

Application period

1.5.2021-20.8.2021

Fees

4000,00 € + VAT 24 % (Price incl. VAT 4 960 €)

Language of instruction

English

Study fields

Management, Administration and Economics
Technology and Natural Sciences
Health and Welfare
Data Processing and Information Technology

Organising unit

Tree – Continuing Education

Mode of study

Multi-modal teaching

Study level

Other studies
Extensive information package on product development and commercialization of health technology products.

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):

  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 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.

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

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.”