Google Analystics

Wednesday, 28 October 2015

ISO 13485 question on advisory notices

A LinkedIn user asked the following question:

Can we claim an (ISO 13485) exemption to the requirement for a procedure for issuing advisory notices? We are not a finished medical device manufacturer, but we will supply components to customers who will assemble them into finished medical devices.

This is a good question and I like the response from Christopher Paris. You can see the full question and response in the LinkedIn discussion, Advisory Notices.