Medical device certification and testing

The certification and testing of medical devices encompasses the technical, regulatory, and quality-related evaluation of products before and after they are placed on the market. This segment is currently characterized by the requirements of the EU Medical Device Regulation, more extensive technical documentation, and stricter evidence of safety, performance, and traceability. At the same time, the demand for specialized testing capacity is increasing, as is the pressure on manufacturers to plan certification processes early and systematically. Accredited testing laboratories and notified bodies play a central role in conformity assessment, market access, and quality assurance. This ensures that the segment remains crucial for safe medical devices and reliable access to the European healthcare market.