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.

RELATED DOCUMENTS Related-Documents-Arrow Periodic Safety Update Report Related-Documents-Arrow Post-Market Surveillance Report Related-Documents-Arrow Procedure for Post-Market Surveillance System
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RELATED DOCUMENTS Related-Documents-Arrow Periodic Safety Update Report Related-Documents-Arrow Post-Market Surveillance Report Related-Documents-Arrow 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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WHAT OUR CUSTOMERS SAY ABOUT US

The documents are well laid out and with our company’s standard formatting they are just falling into place.

Thomas Green

CBCP

Simple gave us an example of how the document could be structured and the different fields to include. Helped us not leave anything out.

Wynn Johansson-Nunez

SVENSKA DENTORAMA AB.

OUR CLIENTS

Post-Market Surveillance Plan - 13485Academy
Post-Market Surveillance Plan - 13485Academy
Post-Market Surveillance Plan - 13485Academy
Post-Market Surveillance Plan - 13485Academy
Post-Market Surveillance Plan - 13485Academy
Post-Market Surveillance Plan - 13485Academy

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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