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Expiration of ISO 14971:2007

  • 1.  Expiration of ISO 14971:2007

    Posted 26-Oct-2022 09:24

    Just a gentle reminder that ISO 14971:2007 transition to ISO 14971:2019 expires from ISO rules perspective, and according to US FDA recognized standards. 

    Why am I mentioning this?  I have seen so many procedures and other documents with 2007 (and even the expired EN ISO 14971:2012 or worse to the never existent ISO 14971:2012) references recently in audits and other contacts with companies that I fear companies are not being diligent in updating to the "state of the art" medical device risk management standard.  

    it seems to be a symptom of the lack of importance and even understanding of medical device risk management.

    How would you do risk management if you were the first patient to use the device you are creating?

    Edwin Bills MEd, BSc,, RAC, CQE, CQA, CMQ/OE, ASQ Fellow
    Overland Park KS
    United States