Get 2 Documentation Toolkits for the price of 1
Limited-time offer – ends March 28, 2024

Expert Advice Community

Guest

ISO 13485 requirements for outsourced processes under MDR

  Quote
Guest
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).
0 0

Assign topic to the user

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:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 29, 2020

May 31, 2020

Suggested Topics

Guest user Created:   Nov 16, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

MDR Deadline

Daniel Kim Created:   Jun 28, 2023 ISO 13485 & EU MDR
Replies: 4
0 0

ISO 13485 as Importer