ISO 14971 compliance helps medical device manufacturers introduce safe medical devices into the marketplace by evaluating and controlling the risks associated with a medical device, and by evaluating a device's interactions with other devices. As the only international standard for risk management for medical devices, ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets and should be incorporated into the medical device life cycle.
E & E Medicals will assist you with ISO 14971 implementation service that follows a 5-step methodology: Gap assessment, quality management system upgrade, training, internal audit, and certification audit. This can be integrated into an ISO 13485 certification program, OR added to an existing ISO 13485 certification. We will provide and generate all the required documentation to meet the requirements of the standard.
To learn more about ISO 14971 medical device risk management, contact us today