Programme

2017, June

The biocompatibility is a preclinical aspect important for any medical device in contact with the human body. The subject is generative of numerous questions and discussions. That is why 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.

During this webinar, the following issues will be discussed:

  • Global approach,
  • General principles of the standard,
  • Proposed assessment methodology,
  • Documents of the LNE/G-MED related to the audit and to the evaluation of files.

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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