ISO 13485 / MDR document template:

Procedure for Infrastructure and Work Environment

This procedure defines requirements for infrastructure and work environment for production of medical devices.

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

There is 1 appendix related to this document. The appendix is not included in the price of this document and can be purchased separately: Record of infrastructure maintenance.

DOCUMENT FEATURES

OVERVIEW

  • Price
    US$ 84.90
  • Compliant with
    ISO 13485 clause 6.3; 6.4.1; 6.4.2; MDR article 10, Annex IX (Chapter I)
  • 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 Procedure for Infrastructure and Work Environment 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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