mdr@noon 15 July 2020
The webinar series offers support for all interested parties about the relevant regulatory issues surrounding the introduction of the MDR.
The entire event will be held in English and is free of charge. It starts at noon and finishes at 13.00 h. Registration will open one month before the date of the webinar.
MDR@noon
15 July 2020
Webinar
12.00 – 13.00 h
Problems with Notified Bodies – and how to solve them
Notified Bodies are indispensable for the Medtech industry. However, NBs with MDR certification are still too few and this creates a dangerous bottleneck. Will all companies have fair and timely access to a NB? Will all medical devices be (re)certified in time? And will all patients continue to have access to the best possible care? These are a few of the questions that the panel will try to answer during the webinar.
Programme
12.00 – 12.05 h: Introduction to the topic
moderated by Dr. Daniel Delfosse
12.05 – 12.15 h: The Experience of a Start-up Company
Speaker: Max Christen (Nexon)
12.15 – 12.25 h: MDR: a system not ready to use – but who cares?
Speaker: Peter Studer (Confinis)
12.25 – 12.35 h: What should you do?
Speaker: Karin Schulze (SFL)
12.35 – 12.45 h: Panel discussion
Panel: Speakers and Daniel Taddeo (SQS)
12.45 – 13.00 h: Q&A session
13.00 h: End
Recording
Upcoming MDR@noon webinars
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19.08.2020 – Audit under MDR rules - QM acc. ISO 13485 or MDSAP?
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21.10.2020 – «Sufficient» data for clinical evaluation
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18.11.2020 – Assessment of the technical documentation under MDR rules
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16.12.2020 – Software, Cybersecurity and Data Protection
Moderation
