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ISO 13485 / MDR document template:

Risk Management File

The purpose of this document is to record and monitor data about the risk assessment.

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.

DOCUMENT FEATURES

OVERVIEW

  • Price
    US$ 19.90
  • Compliant with
    ISO 13485 clause 7.1 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.
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Preview Risk Management File 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.

Buy Risk Management File

US $19.90
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FAQS: BUYING INDIVIDUAL ISO 13485 DOCUMENT TEMPLATES

How will l receive the template?

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

What payments do you accept?

You may pay with major credit card, or via wire transfer from your bank account.

How do you protect my payment details?

We use Secure Socket Layer (SSL) technology, which is the industry standard and considered one of the safest systems for online payment. Your account details and credit card information are encrypted and go straight to the payment processor. We won’t have access to your payment information, and we won’t store it in any form.

Which currencies are accepted?

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