6th session of the Modular EU MDR implementation program: Technical file set up

June 26, 2017 / Europe

Date: 26th of June

Location: Amsterdam, Novotel Amsterdam Schiphol Airport, Taurusavenue 12, 2132 LS Hoofddorp

Language: Presentations will be in English

Subsciption for:   Day pass  € 400,-                
                                  Choice Pass:   € 1750.- (5 sessions)                        

The 26th of June will be the 6th EU MDR Compliance workshop session.  The topic of this session is: Pre market requirements. 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: 
Giovanni Di Rienzo, Global Director Cardiovascular focus team at TüV Süd 
Benjamin Hagendorn, Head of R&D Regulatory Affairs Medical Devices and Filler at Merz Pharmaceuticals
Inette Nieveen, Senior consultant at Qserve
Gert Bos, Executive director & Partner at Qserve

Program:

 9:15   Welcome Coffee/ Tea 
 9:30   Introduction (Gert Bos)    
 9:45   "Structure of a Technical file" (Giovanni Di Rienzo)  
11:00   Break  
11:15   “How to comply with new requirements, how to use lifecycle management of your file to stay in compliance, from portfolio analyses, reflection how ‘difficult’ it is to update files (Benjamin Hagendorn)  
12:00  Lunch 
13:00  Effective use of existing documentation, which changes in QMS are needed to make sure your tech file is always up-to-date” (Inette Nieveen)
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
Inette Nieveen
Post date: March 02, 2017
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