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
Loes Pelgrim, Clinical Operation expert 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 Designing PMCF during the lifecycle of a medical device (Anna Pietersma)
13:30 Partical aspects of PMCF clinical investigation under MDR article 74 (Loes Pelgrim)
16:30 Panel discussion
17:15 Concluding remarks and closure (Gert Bos)
More information about our Qserve experts: