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    ISO 13485 document template:

    Risk Management Review

    This record represents a summary of all activities performed within the risk management process.

    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 Risk Management (according to ISO 14971).

    DOCUMENT FEATURES

    OVERVIEW

    Price
    US$ 9.90

    Compliant with
    ISO 13485 clause 7.1 and MDR Annex I (Chapter I)

    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.

    Want to see what the documents look like?

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

    Preview Risk Management Review 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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    FAQS: BUYING INDIVIDUAL ISO 13485 DOCUMENT TEMPLATES

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    After payment confirmation, we'll send you an email that contains a link to download the document. It's super easy.

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    Which currencies are accepted?

    We can accept 50-plus common currencies for payment, including Swiss Francs, US Dollars, British Pounds and Euros.

    I’m not quite certain that this is the document I need. May I see it first?

    Of course! Click on “Download Free Toolkit Preview”, submit your name and email address, and you’ll have access to a free document preview before you make your purchase decision. You’ll see how the template looks, and how simple it is to complete.