Medical Device Risk Identification, Analysis and Control - ISO 14971 ISO 13485 Record As part of the requirements

As part of the requirements for placing a medical device or IVD on the market

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Medical Device Risk Identification, Analysis and Control - ISO 14971 ISO 13485 Record As part of the requirementsDevice Risk Identification, Analysis and Control Template EN ISO 14971: 2019+A11: 2021 As part of the requirements for placing a medical device or IVD on the market, the manufacturer needs to demonstrate that risk management of the device has taken place. There is a risk management standard for medical devices named EN ISO 14971. This standard states that the manufacturer needs to document the known and foreseeable risks associated with the device.