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  2. Implementing an ISO 13485 Medical Devices Quality ...

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  4. New ISO 13485: Device Companies Have Three Years to ...

    www.raps.org/Regulatory-Focus/News/2016/03/01/24443/New-ISO-13485...

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device ...

  5. ISO 13485: Ex-FDA Official Kim Trautman Gives Advice

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    Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their ...

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  9. https://fr.wikipedia.org/wiki/ISO_13485

    La norme ISO 13485 précise les exigences des systèmes de management de la qualité (SMQ) pour l'industrie des dispositifs médicaux. Elle s'appuie sur les exigences ...

  10. www.iso.org ›  › Explorer par ICS › 03 › 03.100 › 03.100.70

    L'ISO 13485:2003 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement ...