ISO 13485 / MDR document template:

Procedure for Risk Management

The purpose of this procedure is to describe the risk management process in accordance with ISO 14971.

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 5 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: Risk Management Plan, Risk Management File, Risk Assessment Record, Risk Management Review, and Identification of Hazards and Characteristics Related to Safety.

RELATED DOCUMENTS Identification of Hazards and Characteristics Related to Safety Risk Management Review Risk Assessment Record Risk Management File Risk Management Plan Procedure for Production and Service Provision Procedure for Design and Development

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DOCUMENT FEATURES

OVERVIEW

Price
US$ 84.90
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
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.

WHAT OUR CUSTOMERS SAY ABOUT US

The documents are well laid out and with our company’s standard formatting they are just falling into place.

Thomas Green

CBCP

Simple gave us an example of how the document could be structured and the different fields to include. Helped us not leave anything out.

Wynn Johansson-Nunez

SVENSKA DENTORAMA AB.

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Preview Procedure for Risk Management 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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