九月 21, 2021 - 九月 24, 2021
Date: September 21st - 24th 2021
Time: 10:00 AM to 12:30 PM CEST (morning sessions) and 2:00 PM to 4:30 PM CEST (afternoon sessions)
The regulations are already tough – and getting tougher. The MDR and the IVDR place more emphasis on a life-cycle approach to safety, backed up by clinical performance data. Both regulations present stringent requirements for Notified Bodies, control and monitoring by competent authorities. Within this context, staying up to date with the latest news and discussions in the global medical device industry is a complex task.
Join Wiebe Postma on September 21st 2021 in the afternoon for the session 'PMCF under the MDR: the Latest Insights'. In this presentation we will review the PMCF requirements and, based on recent experience with PMCF planning, data collection and notified body acceptance, we will give insights in how to identify and address clinical data gaps using appropriate PMCF methods. Lastly, the role of PMCF in life cycle management will be discussed.
For more information about this event and to register, please visit the LS Academy event website.