Definition

ISO 13485 is the quality management standard specifically for medical device manufacturers. It has strict requirements for risk management, rigorous inspection and traceability for implantable devices, and validation processes beyond ISO 9001. Mandatory for PCB manufacturers supplying medical device components - pacemakers, diagnostic equipment, patient monitors, surgical robots. If you're designing medical electronics, your PCB supplier must hold ISO 13485 certification. Current version is ISO 13485:2016.