Health technology solutions – product development and commercialization (programme)

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):

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

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.

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.