Kategorien: Risikomanagement & ISO 14971
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2 Kommentare

  1. Johan Goris | Mittwoch, 11. November 2020 um 23:21 Uhr - Antworten

    Dear Mr. Johner,

    to convince product test and certification Accredited Labs and Notified Bodies, the Safety Assurance Case approach will indeed only make sense for MD manufacturers … if bridged with Risk Management.

    Therefor I would add ‚Risk Assessment outcome‘ besides ‚intended use‘ as „context“ under paragraph 1.b)
    and refer to annexes C.x of ISO 14971 as non exhaustive checklists under paragraphs 4.b) & 4.c)

    TMHO Examples for „evidence“ under paragraph 1.b) need validation to become evidence.

    The leakage current example for „assumptions“ under paragraph 1.b) should also be validated against risk assessed requirements (eg. leakage currents ifo. correct applied part classification for the intended use).

    Best regards,
    Johan Goris


    • Prof. Dr. Christian Johner | Donnerstag, 12. November 2020 um 16:24 Uhr - Antworten

      Thank you very much, Mr. Goris!

      I appreciate very much your thoughts and added them directly to the article.

      Thanks indeed!

      Best regards, Christian Johner


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