ISO TR 24971:2020
Medical devices - Guidance on the application of ISO 14971
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 - Medical devices - A practical guide.
|Publication type||Technical Report|
|TC/SC||TC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss|
|ICS||11.040.01 - Medical equipment in general|
|File size||3678 KB|
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