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Tag: "Product: ISO 13485/Post-Market Surveillance Report" - Expert Advice Community

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  • 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?