Looking back on Qserve's MDR advanced training course in 2017

On December 11, Qserve organized the final session of the 2017 MDR advanced training course, that consisted of 10 separate events, one day per month. The final session was a full day open panel discussion with the Notified Bodies. Four Notified Bodies (TÜV SÜD, TÜV Rheinland, SGS Belgium and Dekra NL) lined up to answer all of the questions the 70+ delegates had sent in prior to the event, and further discussion spun out of the answers that were provided. The entire day was governed by the Chatham House rule, allowing delegates and panel to speak openly about their challenges and possible solutions to them.

Key topics discussed included transition & implementation, shifting Notified Body, harmonization, clinical evaluation & studies, supply and distribution chain, PMS/PMCF, various consultation processes and QMS requirements. Key take away for me was that we are all learning together, and the only way to come to fast interpretations, and hence allow sufficient progress to implementation, is to have frequent formal but certainly also informal contacts between stakeholders to make sure everyone understands the issues at play, allowing out joint brainpower to come up with and share solutions moving forward.

In this spirit, we would like to continue our MDR and IVDR education program for 2018 (see below), with introductory level courses to engage newcomers in the MDR/IVDR field, but certainly also with specific advanced sessions to progress the cutting edge of the implementation programs.



Upcoming MDR trainings in 2018:

MDR training on 19 & 20 February, Amsterdam, the Netherlands

MDR training on 24 & 25 April, Munich, Germany

MDR training on 27 & 28 June, Frankfurt, Germany

Benefit now from our early bird discount!



Gert W. Bos, PhD, Fraps
Post date: January 02, 2018
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