IVDMD Department Manager
GMED Certification Division, France
Catherine Holzmann has worked in the in vitro diagnostic medical devices field for over 25 years and is currently the In Vitro Diagnostics Medical Device department manager of the Medical Devices Certification Department of LNE/G-MED (Laboratoire National de métrologie et d’Essais), a position she has held since 2006. LNE is an important testing laboratory that has many activities in different sectors. Specific to IVDs, G-MED carries out missions and provides services to manufacturers as the French notified body (0459 – website lne-gmed.com).
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 specialist and she also develops training sessions and conferences.
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IVDR Technical Documentation Pre-conference Workshop
Tuesday, October 3, 2023
8:30 AM – 4:00 PM EDT
Wednesday, October 4, 2023
3:30 PM – 4:30 PM EDT
Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything
Thursday, October 5, 2023
12:05 PM – 12:35 PM EDT
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?
Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT