Module 19 2021

02/06/2021

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

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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

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