Programme

2015, November

The notified body that issued the design or type-examination CE marks regarding specific medical devices or products must approve any substantial changes to those same devices and products.

To help you determine if the changes made require assessment, LNE/G-MED published a Guide on the interpretation of substantial changes, based on the European NBOG’s Best Practice Guide “Guidance for manufacturers and Notified Bodies on reporting design changes and changes of quality system”.

During the webinar we will present the key features of the above-mentioned Guide:

  • Regulatory framework
  • Defining substantial changes
  • Changes to design
  • Changes to materials
  • Changes of the sterilisation process
  • Changes to software
  • Changes to labelling
  • Changes to the manufacturing processes
  • Changes to drug delivery devices

Experts

Christine QUINTONTechnical 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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