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Mr. Bijan Elahi

Mr. Bijan Elahi

Mr. Bijan Elahi

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.