What is ISO 14971 Medical Devices | Scilife

Risk management is a vital part of medical device development and lifecycle processes. Most regulatory agencies, including central authorities such as the European Union and the Food and Drug Administration (FDA), include risk-based methods in their internal processes for medical device and manufacturer evaluations. They also require medical device manufacturers to apply risk management processes in every stage of a device's lifetime. ISO 14971 Medical devices – application of risk management...