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By Edwin L. Bills, member, ISO TC 210 JWG1
Edwin L. Bills, member of ISO TC 210 JWG1, discusses the evolution of risk management standards for medical devices and how ISO 14971:2019's revision (which is also identical to EN ISO 14971:2019) is meant to "close the loop." Based on the extensive changes in Clause 10, all manufacturers of medical devices and in vitro medical devices will need extensive review and possible changes to their production and post-production activities section of their quality systems in order to meet the new requirements.
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