BS EN ISO 14971:2019,Medical Devices—Application Of Risk Management To Medical Devices (British Standard)
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The requirements contained in this document provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.
This document deals with processes for managing risks associated with medical devices. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property.
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BS EN ISO 14971:2019 download