By Richard Featherstone, Emergo Group
The third edition of international standard ISO 14971 (Medical devices—application of risk management to medical devices) is now available. This third version, dated December 2019, cancels and replaces the second edition (ISO 14971:2007). There are a number of changes, some of which relate directly to usability. ISO 14971:2019 is recognized by the FDA as a consensus standard for risk management and is acceptable for submissions. Likewise in Europe, manufacturers seeking to comply with the Medical Devices Regulations (MDR) will need to transition to this new version of the standard when planning their risk management activities.
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