There are important clarifications and updates in ISO 14971:2019 that you should be aware of. ISO TR 24971 is the Technical Report on implementation of ISO 14971 and is not widely known or understood by industry ISO TC 210 and IEC 62A Charges (ISO TC 210 and IEC SC 62A are parent committees of the Technical Committee JWG1 that is responsible for ISO 14971) ISO 14971:2019 compared to 2007 with comments on ISO TR 24971:2020 Revise ISO TR 24971 (or optionally to merge this TR with the standard).clinical benefits and risk-benefit analysis,.production and post-production information,.Clarify the normative requirements, particularly concerning thefollowing topics:.Maintain the key concepts of and the core approach To risk Management.The risk management process itself remains largely unchanged. The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007.
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