Category
Standard
Organisation
Type
Standard
Version
2019
Status
Active
This standard provides an overview of ISO 14971:2019 Medical devices - Application of risk management to medical devices and defines key expectations to support safe and effective implementation. It is intended for implementers, vendors and health organisations seeking a clear, authoritative reference. Published by International Organization for Standardization (ISO), it may be used for procurement, assessment and governance contexts where alignment to recognised practice is required.
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