2017, October

In the frame of CE type and design examination, LNE/G-MED makes available to manufacturers a list of elements to be provided with a view of medical device CE marking.
This list specifies the content of files to be transmitted to the notified body as part of a conformity assessment.
LNE/G-MED is updating those lists and, through this webinar, is informing manufacturers on modifications to take in account when time will come for them to provide such files.

Main items addressed:

Updating / creation of the list of elements to be provided for a Medical Device CE marking in the context of:

  • Initial evaluation
  • Evaluation of a change
  • Renewal Evaluation


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: harmonization of evaluation practices, qualification of the assessors, evaluation of technical files in peer review committees.

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