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The requirement of the PMS plan--suitable indicators and threshold values

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Ashley Fu

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How to understand the suitable indications and threshods used in the continuous reassessment of the benefit-risk analysis and of the risk management as defined in Annex III section 1.1(b) point 3 of MDR?

There are some examples and some basic introduction of the frame of the PMS plan in the ISO/TR 20416:2020(E). However, I haven't found any information about the suitable indications and threshods required in the content of the PMS plan. How and why?

Any comment could be appreciated!
 
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