Safety of patients and users is the primary concern for Medical Device Manufacturers. To ensure safety, Risk Management is a key element in all life-cycle phases of your medical device. In the MDR alone, the word “risk” is cited 243 times.
According to the MDR, manufacturers shall establish, document and maintain a Risk Management System. ISO 14971 Medical Devices – Application of risk management to medical devices is the internationally recognized standard for Risk Management Systems. Although ISO 14971 certification is not possible, compliance is expected as part of MDD/MDR compliance, FDA approval and ISO 13485 certification.