Join us on Wednesday, July 26th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard ?
The biocompatibility is an important preclinical aspect for any medical device in contact with the human body. This subject generates numerous questions and discussions. This webinar gives the methodology expressed in the NF EN ISO 10993-1 (2010) standard and has for objective to harmonize the demonstration of the control of the biological risk.
This webinar will explore the following points:
• Global approach,
• General principles of the standard,
• Proposed assessment methodology,
• LNE/G-MED documents relating to the audit and the evaluation of files.
Topic: Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard?
Date: Wednesday, July 26th, 2017
Time: 2:00 PM Eastern
About 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, evaluation of the technical files in the Comité de lecture.