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Fulfilling documentation requirements of ISO 13485 and MDR in Quality Management System and demonstrating it in matrix

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Guest user Created:   Mar 30, 2021 Last commented:   Apr 01, 2021

Fulfilling documentation requirements of ISO 13485 and MDR in Quality Management System and demonstrating it in matrix

How to fulfil documentation requirements of ISO 13485 and MDR in one Quality Management System and how to demonstrate this in a matrix

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 01, 2021

MDR requires manufacturers to have implemented a quality management system. Requirements regarding the quality management system are stated in Article 10, clause 9. All requirements from the ISO 13485 are in that clause. However, there are some additional requirements like the requirement to document strategy for regulatory compliance, to document the process of issuing UDI number, and fulfillment of the General safety and performance requirements.

Therefore, if you have prepared the QMS according to the ISO 13485, all you have to do is:

  • to prepare those additional requirements and put them on the list of documents
  • to define who is responsible for performing those processes.

For more information, see:

On the following link you can see how our documentation toolkit looks like:

Following link regarding the documentation requirements for both ISO 13485 and MDR can be helpful:

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Apr 01, 2021

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