mdr@noon 21 January 2021
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, starts at noon and finishes at 13.00 h. It is free of charge for members of Swiss Medtech and ASDI as well as for medtech companies based in the canton of Solothurn. Non-members can register for a fee of CHF 60.
MDR@noon
21 January 2021
Webinar
12.00 – 13.00 h
«e-IFU: How to make sure the information gets there»
There are numerous advantages of using e-IFU instead of paper-based IFU. As e-IFU can be made available via internet, the end-user will always have access to the new IFU and there is a clear reduction in paper wastage. However, in accordance with in (EU) regulation 207/2012, manufacturers may provide IFU in electronic form instead of in paper form only under certain conditions, based on a documented risk assessment of the environment in which the device will be used. The webinar will show how this can be handled today. Participants will also have the opportunity to ask their own questions regarding e-IFU.
Program
12.00 – 12.05 h: Introduction to the topic
moderated by Dr. Daniel Delfosse
12.05 – 12.15 h: The experience of a 1st company
Speaker: Natasha Malviya (Alcon)
12.15 – 12.25 h: The experience of a 2nd company
Speaker: Dr. Reinhart Seibl (Geistlich Pharma)
12.25 – 12.35 h: A potential solution
Speaker: Hans Strobel (dokspot)
12.35 – 12.45 h: What should you do? View of a consultant
Speaker: Delphine Huser (Medidee)
12.45 – 13.00 h: Q&A session
13.00 h: End
Moderation
Organisation
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