Risk management for medical devices and the updated BS EN ISO 14971

Risk management has become an important aspect in the regulatory lifecycle of medical devices. International standard BS EN ISO 14971 was originally developed to provide a process to assist manufacturers in identifying the hazards associated with medical devices, assessing the corresponding risks, controlling these risks where needed, and monitoring the effectiveness of the risk control measures. The third edition of BS EN ISO 14971 has been harmonized and listed in the Official Journal of the European Union as providing a presumption of conformity to the European MDR and IVDR without content deviations.