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Day 1, Thursday, Nov 26, 2020
Medical Device Risk Management in Compliance with ISO 14971:2019
Abstract: Medical devices provide benefits but also present risks to the health and safety of patients and users. It is important to balance the benefits of a medical device against the risks that it poses. To be permitted to commercialize any medical device, it is required to perform and document a formal risk management process. ISO 14971:2019 is the DeFacto standard worldwide by which it is possible to satisfy regulatory requirements for medical device risk management.