ISO 13485 / MDR document template:

Post-Market Surveillance Plan

Post-market surveillance plan shows how Post-market surveillance system can be put in place, and which elements need to be covered with a Post-market surveillance plan.

The document is optimized for small and medium-sized organizations - we believe that overly complex and lengthy documents are just overkill for you.

This document is an appendix to the main document, which is sold separately: Procedure for Post-Market Surveillance System.

DOCUMENT FEATURES

OVERVIEW

  • Price
    US$ 19.90
  • Compliant with
    ISO 13485 clauses 7.2.3, 8.2.2, 8.2.3, 8.3.3 and MDR articles 15, 83, 84, MDR Annex III
  • Format
    MS Word 2013, MS Word 2016, MS Word 2019
  • Number of pages
    1
  • Document language
    English

USABILITY

  • Can I edit the document?
    Yes. The document is fully editable – just enter information specific to your company.
  • Can I use this to become certified?
    Yes. The documentation template may be used for ISO 13485 certification audit purposes.
  • Well-defined instructions
    Document templates contain an average of twenty comments each, and offer clear guidance for filling them out.
  • Designed with your company in mind
    The template was created for small and medium-sized businesses.
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Preview Post-Market Surveillance Plan template

  • The document is fully editable so that you can adapt it to your company design.
  • Documents include placeholder marks for all information you need to complete.
  • Each document includes comments and information, which guides you through completion.

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