Bringing a medical device on the market carries a number of legislative requirements. We will help you with the complete preparation of the documentation, so that your company meets these legislative requirements that are related to the placing of the medical device on the market. As a part of the service, we will communicate with the relevant authorities in the state where the medical devices will be marketed.

Medical Devices Regulation (MDR)

In Vitro Diagnostic Device Regulation (IVDR)

Specifics of EU member states