ISO 13485 requirements for outsourced processes under MDR

According to the MDR, all production processes are the responsibility of the Manufacturer, no matter that some of the parts of the production are conducted in other companies.   It means that the manufacturer will need to ensure that sub-contractor has proper processes and documentation in place. This can be done in several ways:

That sub-contractor implements a quality management system by themselves. That Manufacturer provides to the sub-contractor proper documentation and records. Manufacturers need to have control over the processes performed at the sub-contractor. Usually, it is done by quality agreement where all responsibilities of the sub-contractor will be stated; and periodically auditing the sub-contractor.

In the following article, you can find more information:

• How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/