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ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices

ISO 14971:2019

What is ISO 14971:2019? ISO 14971:2019 is the international standard that outlines a comprehensive framework for the risk management of medical devices throughout their lifecycle. It provides manufacturers with a systematic approach to identifying hazards, estimating and evaluating risks, controlling those risks, and monitoring the effectiveness of those controls. This standard is essential for meeting regulatory requirements in global […]

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