7th session of the modular EU MDR implementation program: Clinical PMCF

September 18, 2017 / Europe

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

Presenters: 
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

Program:  

09:15   Welcome Coffee/ Tea  
09:30   Introduction (Gert Bos)    
09:45   Theory on a PMCF (Rene Bombien)  
11:00   Break  
11:15  The process to PMCF Flow of data, which to use in an update of CER. (Enrico Schuur)  
12:00   Lunch  
13:00   How from intended use, the flow of data and which to use in an update of CER. (Anna Pietersma)  
13:45  Workshop  
15:45  Break 
16:30  Panel discussion  
17:15  Concluding remarks and closure (Gert Bos)   
17:30  End

  

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More information about our Qserve experts:

Gert W. Bos
Anna Pietersma
Post date: March 02, 2017
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