We have now reached the first year anniversary of the new European Medical Device Regulation publication. Manufacturers are working on their Gap analyses and implementation strategy while Notified Bodies are going through the notification process. The transition period for the MDR is 3 years and 2020 is coming fast.
This course is designed for Medical Devices professionals working on the implementation of the European Medical Device Regulation 2017/745.
It will allow participants to be able to:
Understand the Structure and scope of the Regulation
Describe the regulatory requirements of Regulation 2017/745
Identify major changes between the Medical Device Directives 93/42/EEC and 90/385/EEC and the Regulation 2017/745
This 2 days course explores two of the most recent evolutions in the Medical Device Industry. Both address a desire to harmonize and establish a more global approach to auditing QMS for Medical Device manufactures.
The transition to ISO 13485:2016
The new version of the ISO 13485 standard published in February 25th, 2016 introduces new timelines and additional regulatory requirements for companies switching their QMS from ISO 13485:2003 and NF EN ISO 13485:2012.
Medical Device Single Audit Program (MDSAP)
A comprehensive approach to Quality System auditing, which includes the development of an international coalition of countries devoted to pooling resources, technology, and services to enhance the safety and oversight of Medical Devices worldwide.
Director of Regulatory, Education and Quality – Lead Auditor
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.