Quality systems and knowledge of regulations are exceptionally important in the health tech sector. As the sector is global, its companies must also know the regulations of other countries.
In cooperation with Tekes, we have produced a training package for health tech companies. The package, entitled Reguloiko (Do they regulate?), makes it easier to understand relevant regulation. To the Reguloiko service
We also offer our members services to help with regulation. The Conforlex information service helps with monitoring statutory requirements. The service is free of charge for members. We also offer expert advice at events, business visits and by telephone.
The association’s work groups also offer information and peer support. In 2017, there are five work groups. Three of them focus on regulations, including software-specific issues, implementing the new IVD and MD regulations and the clinical studies of devices. The fourth group focuses on IoT and the fifth on growth.
Mr. Tom Ståhlberg, p. +358 40 520 4306