Medical regulatory words: compliance, standards, policies and regulations

Continuing Education

Health technology solutions – product development and commercialization (programme)

Tampere University

Extent

15 ECTS

Course dates

3.10.2022-31.12.2023

Application period

15.6.2022-20.9.2022

Fees

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

Faculty or school

Faculty of Medicine and Health Technology

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

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Extensive and up-to-date information package on regulations and requirements for 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 programme offers you the opportunity to expand your knowledge and grow as an expert in health and medical technology.

The programme includes four courses. Two of them are compulsory and two are optional of which you may choose one. If completing the programme is not currently relevant to you, you can also take individual courses as needed.

Target group

This programme is targeted for those who are working or willing to work in health technology companies in different roles in R&D, quality and regulation, production, marketing and sales and management. The programme gives essential knowledge also for health technology start-ups and anyone who wants to expand his or her knowledge about requirements, regulations, and practices when developing and commercializing health technology products for global markets.

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.

Completion of studies

The programme covers the following topics:

Health tech product life cycle, development process and stages
Global regulations, authorities, Notified Bodies, EMA, FDA
From EU directives to regulations, MDR, IVDR, CE-mark
FDA 21 CFR
Software life cycle requirements, IEC/ISO 62304, HL7
Quality Management System (QMS), ISO 13485
Document and record management, traceability
Safety and performance requirements
Risk management, ISO 14971, FMEA
Clinical evaluation, MEDDEV 2.7/1 and ISO 14155, PMCF
Biological safety, ISO 10993 series
Electrical safety, IEC 60601 series
Mechanical testing
Feasibility studies
Design control, verification, validation
Usability and labelling, IEC 62366, UDI, marketing claims, use of symbols, instructions for use, GS1
Go-to-market activities

The program includes three courses. Two of them are compulsory and two are optional of which you may choose one.

Begin with an introductory course (autumn 2022):

Introduction to quality and regulation for health technology products

Deepen your skills with one of the optional courses (spring 2023):

Complete your studies with final course (autumn 2023):

Product development of biomedical devices

You can complete the courses individually or take the entire program at once. Each course is worth 5 ECTS.

It is recommended to start the program with Introduction to quality and regulation for medical product development course and end with Product development of biomedical devices.

Teaching

The programme includes a variety of learning events including theory and practice, visitor case presentations, joint discussions and small group works. Part of the courses also includes a written learning assignment applicable to participants’ own organization.

The teachers of the programme are health technology experts from Tampere University who have experience in companies, organizations, universities as well as in teaching and training adults. In addition, professionals from health tech companies and organizations are involved.

Cancellation terms

Application for the training becomes binding after the last application date.

For cancellation made after the end of the application period, 50% of the participation fee will be charged.
If the cancellation takes place 1-14 days before the start of the training, the entire price of the training will be charged.

In the event of an obstacle, the place of training can be handed over to a colleague. In trainings with separate selection criteria, a place cannot be handed over to another.

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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."

Read Mikael Turunen's experience

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.”