Hello, I am working on the TF of a Class IIb device new document format to be compliant to new EU MDR regulations. I am at section Product and Design Specifications - USER REQUIREMENTS. My question is: what do they mean by User Requirements? the question is not specific enough. thank you for your quick response. Taly Bendayan
It means what the user wants out of this device. So, is it ergonomic for example, is it easy to use it? Look at the instruction for use of the device and see is everything properly described. Is there any special knowledge that users need to have, and special skills, and so on? This information is usually obtained by a usability study.
The most important point is to define which of the suppliers are critical suppliers because with them you need to have a quality agreement. This quality agreement must cover: mutual responsibilities, how the manufacturer will control the supplier, how it will behave in case of a complaint, and the critical supplier must agree to any audits by the manufacturer's notifying authority (if the auditor considers that the manufacturer does not have sufficient control over the supplier).
Another important is for the suppliers of outsourced processes. With those suppliers, there is also the necessity of the quality agreement, but this quality agreement must, in addition to the above, also include the supplier's consent to the statutory audit of the manufacturer's notifying authority, but also to unannounced audits.
In ISO 13485&MDR Documentation toolkit, we have quality agreements for both types of suppliers, and on this link, you can find the preview: