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 is now involved in the biocompatibility assessment of medical devices, but has built strong expertise in the medical writing of clinical evaluation for these devices and the expected regulatory requirements in this field.

CORE COMPETENCIES 

• Over 10 years of professional experience in regulatory affairs relating to medical devices, including biological safety
• Writing biological evaluation plans, biological evaluation reports, toxicological risk assessments, change control assessments, gap analyses and expert reports based on ISO 10993 and ISO 14971 for worldwide requirements
• Evaluating and summarizing biocompatibility and general toxicology data, ensuring compliance with relevant regulatory requirements and standards
• Advising Clients on technical issues related to biocompatibility
• Performing and summarizing literature searches (e.g. ADME profile of substances)
• Working on medicinal substance dossiers (eCTD format) for medical devices incorporating medicinal substances
• 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.

RECENT PROJECTS

• Participated in the CE-marking of several medical devices by ensuring biocompatibility was appropriately evaluated according to current regulatory and normative requirements
• Performed a biological evaluation of a combination product incorporating biological material
• Participated in the compilation of a medicinal substance dossier of a combination product incorporating medicinal substance