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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.

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Webinar Announcement Notified Body Regulatory Updates 10 25The 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.

 

REGISTRATION DETAILS
Christine QUINTON LNE Gmed

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.


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"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
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