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  • 1.  Post-Market Surveillance Metrics

    Posted 24-Sep-2019 08:08
    Can anyone share various metrics pertaining to Post-Market Surveillance activities for presentation at Management Reviews?  Currently, we are able to show summary information from Polls & Surveys around meeting customer requirements and expectations.  I'm looking for a better measurement around the new EU-MDR, possibly changes to benefit / risk ratio or a measure of how good our risk management program is overall?

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    john pellechia
    Director, Post Market Surveillance
    Center Valley PA
    United States
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  • 2.  RE: Post-Market Surveillance Metrics

    Posted 25-Sep-2019 13:42
    Hi John

    The KPI metrics would be to compliance issues.  So an easy one to track is on time submissions, complete submissions.  Your signal management and periodic reports need to be accurate with backup of the number of reports reported in th e time frames for each category.  Make sure you r reports of events of special interest are coded correctly.  In regards to R/B is the accuracy of the SMPC to the AE terms that are coming in.  For new SUSARs or AEs that change in frequency  that might effect the label (B/R) is making sure you analyze them carefully and can support definitively any label changes.

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    John McLane
    VP Clinical Development
    Bourne MA
    United States
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    Original Message


  • 3.  RE: Post-Market Surveillance Metrics

    Posted 27-Sep-2019 09:48
    Hello John,

    You can also include metrics such as complaints days to closure (or % meeting a target closure date of 30/60/90 days), trend complaints/adverse events vs. sales, on time regulatory reporting, etc.

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    Hiral Dutia
    Norwood MA
    United States
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    Original Message


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