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    ISO 13485 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$ 44.90

    Compliant with
    ISO 13485 clause 6.3; 6.4.1; 6.4.2

    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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    Schedule a free presentation, and our representative will show you any document you're interested in.

    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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