MDR@noon 21 October 2020
The webinar series MDR@noon offers all interested parties an insight into the relevant regulatory issues for the medical device industry. The entire event will be held in English and is free of charge. It starts at noon and finishes at 13.00 h.
MDR@noon
21 October 2020
Webinar
12.00 – 13.00 h
«Sufficient» data for clinical evaluation
The demand for clinical data has increased rapidly with the introduction of MDR. Even for older, «well» functioning legacy devices, clinical evidence will be needed tomorrow. What does the term «sufficient clinical data» imply? This question will be discussed in the webinar.
Participants will also have the opportunity to ask their own questions about clinical evaluations.
Program
12.00 – 12.05 h: Introduction to the topic
moderated by Dr. Daniel Delfosse (Swiss Medtech)
12.05 – 12.15 h: How do we define «sufficient data» for the clinical evaluation of our medical products?
Speaker: Peter Münger (Mathys Ltd Bettlach)
12.15 – 12.25 h: A new tool to keep track of your vigilance data
Speaker: Pavel Buncak (VigilanX)
12.25 – 12.35 h: How to appreciate clinical data
Speaker: Jasminka Roth (Tao of Excellence)
12.35 – 13.00 h: Q&A session
Moderation
