Amelia Kara is a Doctor of Medicine, Specialist in Cardiology and obtained an Inter-University Degree of Investigator in Clinical Research from the University PARIS 7. Prior to joining the GMED NA team, Amelia practiced several years in Hospital Specialized in Cardiac Surgery and then 4 years at LNE-GMED as Evaluator and Project Manager in the Certification of Implantable Medical Devices. At GMED NA, Amelia is the Internal Physician in charge of the evaluation of Clinical data and perform RTAs in connection with the clinical strategy.
2019 GMED North America Forum
Past event
Calling on Medical Device enthusiasts of the European Regulatory framework (RA/QA professionals, Medical Device Experts, Auditors and Manufacturers)
About the training
We are happy to announce our Annual GMED North America Forum. Meet us for a day of Regulatory and Technical updates and information. We have created an exciting program with a strong emphasis on the new (EU) Regulations 2017/745 for Medical Devices and 2017/746 for In- Vitro Diagnostic Devices. The forum format will feature presentations by our GMED national and international regulatory experts with facilitated workshops.
Découvrez le programme
Transition to EU Regulations 2017/745 (MDR) & 2017/746 (IVDR)
Medical Device Usability – Latest Standards and European Requirements
Clinical evaluation under the aegis of the new Regulation (EU) 2017/745 on Medical Devices
Person Responsible for Regulatory Compliance (PRRC)
Medical Device Usability – Latest Standards and European Requirements
Clinical evaluation under the aegis of the new Regulation (EU) 2017/745 on Medical Devices
Person Responsible for Regulatory Compliance (PRRC)
Regulatory & Quality
Auditor
Technical Documentation Assessor
Meet the Speakers
Dr. Amelia Kara
The Clinical evaluation under the aegis of the new regulation 2017/745
Sebastien Rosset
Applicable standards for active medical devices for CE marking
Sebastien Rosset is a Certification Project Manager and Lead Auditor at GMED North America. He received an Engineering degree specializing in measurement and automation from INSA CVL (France) and a master’s degree in electronics from the University of Montpellier II in France. Prior to joining GMED North America. , Sebastien worked as a test engineer and technical manager in the Medical Device Industry in the French National Laboratory (LNE, the parent company of GMED North America. ). Sebastien has been working since 2011 on performing tests on active medical devices, following the standards IEC 60601, 62366, 62304. At GMED North America., Sebastien is a Lead Auditor specialized in active medical devices and software.