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Transition to ISO 13485:2016, 1 Day Course.

About the training

Training ISO 13485 2016With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.

Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.

Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Florianne Torset Bonfillou LNE Gmed

Florianne Torset-Bonfillou Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.

Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at LNE/G-MED North America. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. She holds a professional certificate in Quality, Safety and Environmental Management. Prior to joining LNE/G-MED, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager.  At LNE/G-MED, Florianne is a Senior Design Dossier Reviewer and Lead auditor. She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

Check out the Program

Day 1
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