mdr@noon 19 August 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
19 August 2020
Webinar
12.00 – 13.00 Uhr
Audit under MDR rules – QM acc. ISO 13485 or MDSAP?
The goal of the MDSAP Programme is a worldwide standardisation for the interpretation of QM requirements by auditors. This would lead to a reduction of inspection efforts and total audit times. How far are we along the way? Can you include the MDSAP into your next ISO 13485 audit? 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 - 12.20 h: ISO 13485 and/or MDSAP? What should you do?
Speaker: Michael Maier (Medidee)
12.20 – 12.35 h: The view of an established medtech company
Speaker: Ms. Susana Mogensen – Global Head of QA/RA, Occlutech
12.35 – 12.45 h: Panel discussion
Panel: Speakers and Julia Jaekle (SQS)
12.45 – 13.00 h: Q&A session
13.00 h: End
Recording
Upcoming MDR@noon Webinars
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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
