From Paper to Practice: Technical Documentation Essentials for Medical Device Software
Watch our webinar to gain practical insights on crafting essential technical documentation with confidence.
We’ll take you step-by-step through interpreting MDR requirements, choosing the right accredited Notified Body, and navigating the qualification and classification process—all with a focus on your software’s Intended Purpose.
Don’t miss this opportunity to ensure your documentation is not just compliant, but also clear and comprehensive.
Agenda
00:00 – Introduction
03:09 – Qualification and Classification of MDSW
11:24 – MDR Technical Documentation
25:42 – UDIs for MDSW
29:27 – Accredited Notified Bodies
37:46 – CE certified and then what?
11:24 – MDR Technical Documentation
25:42 – UDIs for MDSW
29:27 – Accredited Notified Bodies
37:46 – CE certified and then what?
45:53 – Q&A
Speaker
Caroline Aernouts
Senior Consultant RA MD
Expert knowledge in Regulatory Affairs
Let’s get your medical device to market. We support you from concept to launch in the full lifecycle. Our services go from legal, manufacturing, regulatory, and clinical to commercial support.