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Risk Analysis for Medical Devices
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Almost every medical device regulatory agency has to at some point address risk management. They include the FDA principles in their processes throughout their internal process when reviewing device submissions and conducting inspections and audits. The U.S. FDA, Canada, Australia and Japan all require companies to have a risk management process designed for their products. These regulatory agencies endorse ISO 14971 Medical devices -- Application of Risk Management to Medical Devices, and in addition ISO 14971.
This topic was modified 1 year ago by bpadgett@msm.edu
Posted : 14/04/2023 4:09 pm