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nonconforming materials report

Post Market Surveillance and Feedback

Post Market Surveillance is discussed within ISO 13485:2016 as an input for Monitoring and Measurement, as well as Improvement.  Feedback is identified as an Input to Risk Management as well as Management Review.  But, what is Post Market Surveillance?  What methods can be used to obtain Post Market Feedback?  How can this information be used?  This White Paper focuses on Post Market Surveillance and Feedback according to ISO 13485:2016.  The discussion provides a definition for Post Market Surveillance and methods for obtaining and using this information.

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