Learn about the updated EU MDR’s strong emphasis on safety and risk management.
Tag: European Union
ISO 13485: The Global Quality Management Systems Standard for Medical Devices
With the explosion of medical devices and manufacturers, a need was realized to develop a medical-device-specific standard based on ISO 9001. The result is ISO 13485.
Medical Device Regulations Part 2 — Europe
An introduction to The European Union Medical Device Regulation (EU MDR) 2017/745, CE certificates and the companion standard European Union Invitro Diagnostic Regulation (EU IVDR) 2017/746.