Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

ISO 14971:2019 History

 ISO 14971-1:1998 - Medical devices -- Risk management -- Part 1: Application of risk analysis  ISO 14971:2000 - Medical devices -- Application of risk management to medical devices  ISO 14971:2007 - Medical devices -- Application of risk management to medical devices  ISO 14971:2012 – Minor corrections and cross linkages to MDD, IVDD, AIMD as defined by Annex Z  ISO14971:2019 – Current Standard

ISO 14971 1:1998

ISO 14971:2000

ISO 14971:2007

ISO 14971:2012

ISO 14971:2019

The Organisation for Professionals in Regulatory Affairs

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Scope

 International Standard  Specific to medical devices including IVDs  Requirements for all stages of medical device and IVD life-cycle  Does not require a Quality Management System  Can be an integral part of a QMS

The Organisation for Professionals in Regulatory Affairs

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