Marie-Charlotte holds a PharmD and a Master degree in Toxicology. She started at NAMSA in 2011, where she was involved in the management of biocompatibility testing. She then moved into consultancy, working in both areas of biological evaluation and clinical evaluation of medical devices. She participated in the preparation of many Biological Risk Assessments and Clinical Evaluation Reports (CERs) of all classes of medical devices, including high-risk medical devices (i.e., implants, animal tissue containing devices or combination products). Marie-Charlotte has strong experience with the medical writing of clinical evaluation of medical devices and the expected regulatory requirements in this area.

CORE COMPETENCIES 

• Nine (9) years of professional experience in regulatory affairs relating to medical devices
• Writing CERs on medical devices in multiple domains per MEDDEV 2.7/1 rev 3 (2009) and MEDDEV 2.7/1 rev 4 (2016) and compliant with the Essential Requirements of European Medical Device Directive (MDD) 93/42/EEC amended by the directive 2007/47/EC, as well as in compliance with the Medical Device Regulation (MDR) 2017/745
• Providing regulatory support to manufacturers, resulting from clinical evaluation recommendations
• Delivering training sessions to manufacturers on clinical evaluation of medical devices according to the literature route to comply with MEDDEV 2.7/1 rev 4 (2016) requirements and MDR
• Providing consulting services to manufacturers with clinical evaluation of medical devices for CE-marking or post-marketing applications
• Involvement in Medical Writing (MW) Task Force Teams: Education Team – training new MW employees and developing training plans and methods; Template Team – managing updates and revisions to MW templates; and Process Team – developing strategy and improvement of MW process
• Management of in vivo biocompatibility tests, including irritation, sensitization, acute systemic toxicity, pyrogenic test, in vivo micronucleus mouse bone marrow, etc.
• Delivering biological risk assessments according to ISO 10993 requirements in multiple domains

RECENT PROJECTS

• Development of several CERs to meet the MDR requirements of a large portfolio
• Development of the Post-Market Clinical Follow-up (PMCF) plan following the outcomes of a CER
• Preparation of the clinical safety and usefulness dossier of a combination product