9/27/2023 0 Comments Iso 13485 certified![]() ![]() ![]() A certificate issued by an independent accredited certification body ensures that the quality management system of the supplier and the manufacturer of medical devices is implemented, documented and used in accordance with the requirements of ISO 13485. The standard includes criteria for the full range of quality management system for medical devices. PRINCIPLES OF THE CERTIFICATION ACCORDING TO ISO 13485ĭue to the growing demands on the quality management system of suppliers and manufacturers of medical devices, ISO 13485:2016 has been developed.
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