Sr Product Assessor
GMED North America
Florianne is a Senior Regulatory Professional and Senior Product Assessor at the notified body GMED, where she leads evaluations of high‑risk medical devices with a focus on cardio‑ and neurovascular technologies, as well as critical special processes including sterilization and packaging.
She has played a key role in major global regulatory initiatives, contributing to the UKCA designation, MDR/IVDR transition strategy, and implementation of the MDSAP program. With a strong academic background in Biology, Chemistry, and Quality Management, Florianne first worked in the pharmaceutical and medical device industry before joining GMED as an Assessor and member of the Quality & Regulatory Support team.
Over the past eight years, she has provided extensive guidance to internal teams navigating the transition to the European Regulations EU 2017/745 and EU 2017/746, in addition to supporting GMED’s UKCA designation efforts.
In parallel to her assessment activities, Florianne is an experienced trainer, delivering courses on European medical device regulations, Quality Management Systems, Risk Management, and a wide range of regulatory and quality topics.
Solutions Circle (5): How Can a Strong Quality System Support Manufacturers’ Regulatory Strategy?
Thursday, March 5, 2026
1:45 PM - 2:15 PM East Coast USA Time