Programme

2017, March

Since June, 2016, a revision 4 of the MEDDEV 2.7.1 was published and replaces the version 2009. This document accompanies the spirit of the new Regulation of the medical devices which should be published during 2017.

It is important that the manufacturers of medical devices use and master this document of orientation and best practice within the framework of the evaluation of the clinical data. Indeed, this one contains strengthened provisions to perfect the demonstration of the conformity with the essential requirements relative to the performance and to the clinical safety of medical devices, in the more general purpose to protect the health of the population.

During this webinar, the following issues will be discussed:

  • Novelties of the version 4 of MEDDEV 2.7.1
  • Update of the quality documents of LNE/G-MED

Experts

Christine QUINTON Technical File Evaluation Manager - LNE/G-MED

Christine QUINTON is a materials engineer. She consolidated her knowledge in Berlin, where she worked for a medical device manufacturer during four years. After that, she worked as an auditor in a German notified body. In 2004, she joined LNE/G-MED and broadened her areas of expertise. She worked as a Certification Project Manager, an assessor, an auditor and a trainer. Since April 2012, she manages the technical file evaluation activities for class III MDs: harmonisation of evaluation practices, qualification of the assessors, evaluation of the technical files in the Comité de lecture.

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