ISO 14971 is the International Standard for application of risk management to medical devices. It is recognized globally by regulatory authorities as the definitive standard to ensure continued safety and effectiveness of medical devices throughout their product lifecycle.
In this free video lesson from our fully on-demand ISO 14971 certification course, I explain the requirements for a risk management process outlined in Clause 4.1.
If you read this clause carefully, you can understand the purpose of a risk management process and its key elements. A clear understanding of the purpose is useful to develop a plan for evaluating the suitability and effectiveness of the risk management process.
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