ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?

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By Tony Parise

ISO 14971 for medical device risk management is in the final stages of an important update slated for publication this year. While ISO has specifically said the intent of the revision isn’t to rework the risk management process, subtle changes in the latest version could impact medical device manufacturers in a variety of ways.

The changes include a significant reorganization of content, new terms, and more detailed requirements around evaluating residual risks and collecting

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