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PMS process

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Guest user Created:   Apr 14, 2021 Last commented:   Apr 15, 2021

PMS process

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Apr 15, 2021

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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