Over the course of these 2 days, the attendees will learn about the new requirements to plan an efficient transition and ensure they are ready to:
Gain an understanding of the changes introduced by both European Medical Device Regulation – EU MDR 2017/745;
Assess the impacts of those changes on their organizational and structural activities
Address the new Quality Management System (QMS) requirements;
Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s);
Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management;
Implement the requirements for labelling , the Unique Device Identification (UDI) and EUDAMED, and;
Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.);
About the trainer
Florianne Torset-Bonfillou Director of Regulatory, Education and Quality – Lead Auditor
Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at GMED 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 GMED NA, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager. At GMED NA, 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.
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