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ISO 13485 / MDR document template:

Technical Documentation Procedure

A procedure that describes how to prepare the Technical Documentation template and how to complete the individual sections. It also indicates what needs to be taken into account when verifying that individual reports have been prepared in accordance with the requirements of the MDR and other relevant regulations.

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

There are 2 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: Technical Documentation for Medical Device and Summary of Safety and Clinical Performance.

DOCUMENT FEATURES

OVERVIEW

  • Price
    US$ 79.90
  • Compliant with
    MDR Annex II
  • Format
    MS Word 2013, MS Word 2016, MS Word 2019
  • Number of pages
    6
  • 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 Technical File Procedure 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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