Post Market Surveillance Indicators and Analysis method

Yaut

Registered
#1
Hello,

I'm writting our PMS template, I already have all the information necessary. The two remaining problems are : How to find good indicators ? And, What methods of analysis can we use to analyze our data?

I know this is dependent on our device but do you have a method to find relevant indicators? I do not see how to proceed .. Thank you very much !!
 
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yodon

Staff member
Super Moderator
#2
The intent of postmarket surveillance is to drive continual review of safety and efficacy.

Complaints, adverse events, etc. are inputs to the assessment. Is there anything in the data that indicates you missed the mark on your risk assessments? If so, are additional controls warranted? Is the UI promoting safe and effective use or are there indications that users aren't using it in the way intended? Does the data suggest it's not as effective as claimed? Are there improvements that are indicated that could increase safety or efficacy?

Not sure if that helps but, as you indicate, this is very much driven by device specifics.
 
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