|NSF INTERNATIONAL||Director, Regulatory Team, IVDs and Medical Devices||United Kingdom|
| Final stretch to MDR/IVDR implementation: How are companies revising their strategy to comply with the key requirements and associated timelines? |
Laurence Matheron has over 15 years’ experience in European medical device and in vitro diagnostic device regulation. Her expertise includes economic operator strategies, EUDAMED planning, transition strategy development, classification decisions, BREXIT impact assessments, technical documentation and quality management system procedures gap assessments, and training.
Dr. Matheron previously worked at the UK Medicines and Healthcare products Regulatory Agency (MHRA) leading a European project on medical device market surveillance. She also served as the Head of the Department of Consumer Medical Devices and Cosmetics at the French Agency for Medicines and Health Products Safety (ANSM). Earlier, at the French Health Products Safety Agency (AFSSAPS), she headed a team in charge of vigilance for in vitro diagnostic medical devices. She also worked in health technology assessment as a project leader in the Department of Medical Device Assessment in the French National Authority for Health (HAS).