IVDMD Forum

Lionel Dreux has served as President of GMED, a subsidiary of LNE, since it was created in 2018. An electronics engineer and a graduate of the National Institute of Electrical Engineering, Electronics, Computer Science, Fluid Mechanics and Telecommunications (ENSEEIHT) in Toulouse, Lionel Dreux joined the French National Metrology and Testing Laboratory (LNE) in 2000 after several years in aeronautics. For eight years, he served as Deputy Director of LNE’s testing division (establishing and developing testing activities, particularly for medical devices).  He then spent 10 years as Director of LNE’s Scientific and Industrial Metrology Center (metrology and calibration research), which boasts over 250 associates, engineers, researchers, and technicians. In 2018, he led the subsidiarization of GMED for LNE and stepped into his role as President on August 1st, 2018.

Catherine Holzmann has worked in the in vitro diagnostic medical devices field for over 30 years and is currently the In Vitro Diagnostics Medical Device Department Manager of the Medical Devices Certification Division of GMED, a position she has held since 2006.

She began her career as a Marketing Manager at Sanofi Diagnostics Pasteur and then lead her career to regulatory affairs position at Bio-Rad Laboratories. She was graduated Doctor in Pharmacy in 1985 and received a PhD from internship in Biology in Paris in 1989.

Catherine is a qualified QMS Lead Auditor, a Product Reviewer and she also develops training sessions, participate to conferences and contribute to the MDCG Mirror Working Groups.

Yann Le Grand holds a Doctorat in Pharmacy and a specialised Master 2 in the field of medical devices from the Faculty of Pharmacy of Chatenay-Malabry (France).

Following professional experiences in the sterilization of medical devices and dental industry, Yann joined GMED as Regulations Project Manager in 2018 and is currently working on the implementation of regulations (EU) 2017/745 and 2017/746.

With a background in Biomedical Engineering, Aurélie joined GMED as a Certification Project Manager. She held positions as auditor and evaluator of technical documentation in the field of active devices, then as department manager in charge of implantable devices, and as industrial manager before taking up her current position as Regulatory Affairs Manager.

In her current position, she is in charge of the analysis of regulatory texts and is involved in the development of the certification missions of the notified body in compliance with standards to apply.

The experience acquired within GMED has enabled her to master the regulatory and standard items, essential to the sector of activity that is the certification of medical devices, but also to grasp the problems and issues linked to the industrial world.

After working for several years in academic research on microbial evolution with a predilection for in silico genome analysis, Gaëlle Bisch was involved in the design of medical devices combining reagents and dedicated softwares, aimed at predicting microbial resistance to antibiotics. She is currently a certification project manager, file evaluator and auditor at GMED, with a specialization on IVDMD software and microbiology.

Béatrice is the Technical Director of GMED, she is a Biomedical Engineer graduate from the University of Technology of Compiègne (France).

Starting her career at the French Ministry of Health, Beatrice also performed the functions of Certification Project Manager, Auditor, and Product Evaluator, before moving to responsibilities relating to the management of the certification body’s quality system, as well as the auditor’s qualification management. Thanks to various experiences and since May 2018, she has been appointed Technical Director in charge of maintaining and improving GMED’s quality system, ensuring the competence of the stakeholders as well as defining and improving assessment and certification methods.

Caroline Boulvin holds a PhD in molecular biology and worked for twenty years in the in vitro diagnostics (IVD) industry, holding various operational and strategic marketing positions, before joining SIDIV in 2017.

Céline LAMOUREUX has nearly 15 year-expertise in the field of  Medical Device/IVD Medical Device within the Regulatory Affairs department.
She started her career in the pharmaceutical industry at Laboratories Gilbert.
In 2014 , she joined ELITech Clinical Systems, a company specialized in design, production, control and sales of clinical chemistry products for In Vitro Diagnostics (IVD), as a Regulatory Affairs Engineer.
And since 2017, she has been piloting  in this society the project on the implementation of the new European IVD regulation and ensuring compliance with the technical documentation.

Sophie Réhault has been working in Quality and Regulatory Affairs management for nearly 20 years. She has worked for medical devices companies such as Mauna Kea Technologies, specialist of endomicroscopy, or BALT, specialized in the design and production of medical devices for interventional neuroradiology.

In 2020, she joined the international group STAGO, expert in the design, development and production of In Vitro Diagnostic Medical Devices for Hemostasis. She takes the position of Market Access Director, in charge of the management of Regulatory and Clinical Affairs.

Dr. Jeannette Fareh joined GMED in September 2020 and has been qualified as a Product Reviewer and Internal Clinician. She works in the GMED Certification branch for the in vitro Diagnostic Medical Device Department. Dr Fareh began her career as a Research Director at Angiogene Inc (AccelLab) in Canada after two post-doctoral positions in the prevention and treatment of cardiovascular diseases thanks to numerous awards (Merck, Medical Research Council of Canada, Heart and Stroke Research Corporation of Canada, Canadian Society of Hypertension, Programme Lavoisier). After 10 years in Canada, Dr Fareh joined Bio-Rad Laboratories for 14 years as a R&D Manager in the Biomarker Unit dedicated to innovation in the diagnosis of metabolic, chronic and infectious diseases. Dr Fareh was principal investigator of national and international collaborative research programs in clinical diagnostics ; she participates to scientific & clinical committees and Master 2 training in Innovative Diagnostics. Dr Fareh holds a PhD in Physiology/ Biology of the University of Claude Bernard of Lyon I and a PhD es science (HDR) from the University of Medicine of Montpellier.

Ségolène COLRAT is a Certification project manager, auditor and product assessor at GMED since more than 10 years in the In vitro diagnostic department. She is in charge of the regulatory conformity assessment according to the Directive 98/79/EC and the Regulation (EU) 2017/746 of IVD-MD as well as the certification according to the ISO 13485 standard and the MDSAP.

Previously, she has 10 years of experience in a start-up company in the field of therapeutics and diagnostics as quality manager and assistant in clinical affairs for the development of therapeutic molecules and diagnostic tools based on DNA chip technology.