Risk Management of Medical Devices Ensuring Safety and Efficacy through ISO 14971

摘要

The provision of safe and effective devices for patients and health care users is the basis for standards and regulations for medical devices the world over. Over the past several decades those standards have been primarily product specific technical standards. As the sophistication within the precincts of the health care environment has increased it has become necessary to move to a system approach to standards and the supporting regulations. The system standard, ISO 14971:2000, Medical Devices-Risk Management -Application of Risk Management to Medical Devices, has become a key basis for much of the standards and regulatory approach in medical devices today. With this approach the safety and efficacy of medical devices in an increasingly complex health care environment is medical devices greatly enhanced.