I am new to the PMS process, we have our procedure and plan in place for a class i medical device. Is this template the report that will be submitted for the audit? or this this report tempate just to be used for PMS reviews?
Also can data be analysed in terms of figures (i,e percentages) or can it be presented in graphical form with appendices?
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This document, Post-Market Surveillance Report, is a report that you need to have for class I medical devices and that you will submit it for the audit.
You can use any form for presenting data that you find useful, both figures and graphical form with appendices.
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Apr 15, 2021