Regulatory training on health and medical technology
Courses
Our courses give you a broad and up-to-date knowledge of regulations, requirements, and practices. You can complete your studies flexibly while working, and you can do the course assignments in connection with your own work. You can participate in the training on site in Tampere or remotely.
The courses are
- Introduction to quality and regulation for health technology products
- Standards, interoperability and regulation in health informatics
- Global regulations and standards for biomedical products
- Regulatory requirements for design and manufacture of medical devices
The courses are organized annually. You can join to the next implementation if the course you want to participate is not available for application at the moment.
Application is open for the following courses
Target group
Courses are 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. Courses give 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.
Person responsible for regulatory compliance
For those who would like to have a competence to be “Person responsible for regulatory compliance” these courses offer 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.
Tailored trainings for organisations
Do you need training for your own group and according to the company's needs?
In the customized option, the training content, themes and teaching methods are planned together with you and according to your needs. This is an excellent option when you want to focus on a specific issue, work on a specific case under guidance, or familiarize the personnel with the regulations, requirements and practices of the industry.
We will be happy to tell you more about the possibilities.
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, 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.”