Health technology solutions – product development and commercialization (programme)

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

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.

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/li>
• Design control, verification, validation
• Usability and labeling, IEC 62366, UDI, marketing claims, use of symbols, instructions for use, GS1
• Go-to-market activities

Why participate?

Unlike many other products, health technology products like medical devices, in vitro diagnostic devices, supplies, software, and advanced therapy medicinal products (ATMPs) are tightly regulated and controlled by the authorities. Up-to-date knowledge of regulations, requirements and standards is important for all those working in the field, as they apply to products throughout their life cycle.

When health technology products are developed and commercialized, the requirements, standards and regulations in different markets like USA, EU, China and Japan need to be considered – from research and development phase to marketing and after sales services. If you are or will be part of any kind of company in biomedical or health technology field, you will benefit greatly from this programme.

On 26 May 2021, the EU Medical Device Regulation (MDR) will become fully applicable, following the transition period, and the EU In-vitro Diagnostic Medical Devices Regulation (IVDR) have to be complied by 26 May 2022. These regulations require all companies to have a “Person responsible for regulatory compliance” whose required expertise in the field can be verified. This person also has significant responsibilities and obligations in quality management matters. We have built this programme to offer a formal additional education for this profession.

Qualifying for the certificate

To qualify for the certificate, you must 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. After completing the programme, you will receive a certificate to prove your competence. Additionally, a work-based training is required to achieve the qualification to work as a regulatory compliance person.

Teaching

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

The teachers are health technology experts 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.

Course contact persons

Minna Veiranto, minna.veiranto [at] tuni.fi

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.