Date: Monday 18th of September
Location: Amsterdam, Novotel Amsterdam Schiphol Airport, Taurusavenue 12, 2132 LS Hoofddorp
Language: Presentations will be in English
Subscription for: Day pass € 400,-
Choice Pass: € 1750.- (5 sessions)
The 18th of September will be the 7th EU MDR Compliance workshop session. The topic of this session is: Clinical PMCF. Dr. ir Gert Bos, EU-MDR specialist and leading Qserve’s efforts around the EU-MDR will moderate the sessions. He will bring the audience up to speed with the latest developments.
During the workshop in the afternoon, Gert will present a hypothetical manufacturer, and the attendees will be trained on best practices how, when, and what to implement for compliance with EU-MDR. The day will be closed with an interactive panel discussion where you can ask our speakers all you want to know for the implementation of the EU-MDR.
Participation in all 10 sessions will ensure your company has the tools to implement EU-MDR compliance within your organization, in a practical approach. Alternatively, you can choose to select topics or join specific sessions of particular interest to your company.
More information: European MDR workshop program
Enrico Schuur, Director Regulatory Affairs at Medtronic International
Rene Bombien, Cardiac Surgeon at (TüV)
Anna Pietersma, Principal Consultant at Qserve
Gert Bos, Executive Director & Partner at Qserve
09:15 Welcome Coffee/ Tea
09:30 Introduction (Gert Bos)
09:45 Theory on a PMCF (Rene Bombien)
11:15 The process to PMCF Flow of data, which to use in an update of CER. (Enrico Schuur)
13:00 How from intended use, the flow of data and which to use in an update of CER. (Anna Pietersma)
16:30 Panel discussion
17:15 Concluding remarks and closure (Gert Bos)
More information about our Qserve experts: