In the context of EC type and EC Design examinations, LNE / G-MED provides Medical Device Manufacturers with a list of the elements to be supplied for the CE marking of their medical devices. The list shall specify the content of the Dossiers to be submitted to the Notified Body as part of their conformity assessment. LNE / G-MED update this list and through this webinar, inform Medical Device Manufacturers, of the changes to be taken into account for future dossiers submissions.
The webinar addresses the following main points:
Update /creation of the list of elements to be provided for the CE marking of a Medical Device in the context of:
• An Initial evaluation
• Evaluation of a change
• Evaluation of a renewal
The presentation will be followed by a session of questions / answers with our expert.
Topic: CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical DocumentationAbout the presenter: 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 for 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, and evaluation of the technical files in the Comité de lecture.