Most manufacturers by now should already have learned and implemented many of the MDR QMS requirements, and have created procedures and templates to support the Post Market Surveillance, Post Market Clinical Follow up and Clinical Evaluation processes. For these examples of processes, the MDR has introduced very descriptive requirements for manufacturers to follow. But as we read the MDR carefully, we will learn that there are other processes that need to be addressed in the QMS. For these areas, the MDR provides the foundational regulatory requirements but may not explicitly state how the requirement can be addressed in the QMS or may not mention at all that these processes shall be covered in the manufacturer’s’ QMS.
This webinar is intended to cover some of these areas that are not very obvious in the MDR, yet very crucial that manufacturers account for them in the QMS for MDR readiness.
I am delighted to share some quick feedback. This is the second training session led by Rania that I have attended. She is just fantastic. Knowledgeable, pragmatic, genuine, approachable. She is clearly an expert but never talks down to her audience. I appreciate her conversational style and willingness to say “I don’t know, but I’ll get back to you"
Webinar Attendee