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

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:

• EU MDR Article 10 https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

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

• ISO 13485 & MDR Integrated Documentation Toolkit https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

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

• EU MDR Checklist of Mandatory Documents https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents