ISO 14971 Medical Device Risk Management Training

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  • Published date: October 29, 2020
    • san Jose, california, United States

This course will give an introduction into the new ISO 14971:2019 and how to create a risk management file according the ISO 14971:2019. It will give you an overview about the requirements the interfaces to Post-Market-Surveillance, Clinical Evaluation, Bench-Testing and Life-Cycle-Management. and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.

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Ashutos Swain
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