![]() ![]() The certificate, issued by an independent accredited certification body, guarantees that the quality management system at the supplier and manufacturer of medical devices is implemented, documented and used in accordance with the requirements of EN ISO 13485:2016 The standard contains criteria for the full range of quality management systems for medical devices. Due to the higher demands on the quality management system of the supplier and the manufacturer of medical devices, the EN ISO 13485: 2016 standard was prepared.
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