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ISO 13485 requirements for outsourced processes under MDR

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Guest user Created:   May 29, 2020 Last commented:   May 31, 2020

ISO 13485 requirements for outsourced processes under MDR

My concern is to know what will the requirements be when MDR will go live ( May 2021) in order to conform to ISO 13485 in the sub contractors position ( not the manufacturer but sub elements or services of the actual medical devices, the one, the manufacturer is marking).
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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.

Expert
Kristina Zvonar Brkić May 31, 2020

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:

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