Marie-Eve Cluzel-Valentin joined NAMSA in 2011 to provide regulatory support to medical device manufacturers in multiple areas, including biocompatibility and microbiological evaluations, clinical evaluations reports (CERs) and submissions to Notified Bodies. She holds a PharmD, a General Chemistry Engineer high school diploma and a PhD in microbiology and molecular biology.

CORE COMPETENCIES

• More than 10 years of professional experience in regulatory affairs related to medical devices (all classes)
• Biological safety evaluation plans, biological risk assessments, 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
• Conducting training sessions to manufacturers on biocompatibility according to ISO 10993 requirements
• Developing testing strategies and corresponding protocols to support single-use and reusable medical device validations
• Reprocessing: cleaning validations, disinfection validations, sterilization (steam and radiation), preparing Instructions for Use (IFUs) outlining device reprocessing methods with consideration of user needs and practices and technical documentation for demonstrating the selection of worst cases devices for reprocessing validations
• Providing consulting services to manufacturers for CE-marking or post-marketing applications

• CERs in regulation with MEDDEV 2.7/1 (2016) directive 2007/47/EC, Active Implantable Medical Device Directive (AIMDD) 90/385 EC amended by 2007/47 EC and with MDR 2017/247

• Providing regulatory support to IVD manufacturers by overseeing gap analysis of regulatory strategies, submissions and key documents pertaining to EU In Vitro Diagnostic Directive (IVDD) and EU In Vitro Diagnostic Regulation (IVDR), covering Performance evaluation reports
• Training sessions to manufacturers on clinical evaluation of medical devices
• Performance evaluation reports in accordance with IVDR, encompassing scientific validity, analytical and clinical data and technical dossiers development and upgrade from IVDD to IVDR

• Consulting services to manufacturers with clinical evaluation of medical devices for CE-marking or post-marketing applications
• Training sessions to Notified Bodies and manufacturers on clinical evaluation of medical devices
• Training sessions to Pharmacy students in Faculté of Pharmacie, France
• Standard operating procedure (SOP) development and clinical trial management—multicentric post-market studies to comply with FDA requirements

RECENT PROJECTS

• Optimized validation strategies for multiple critical medical devices requesting cleaning, high-level disinfection and sterilization testing in compliance with European and U.S. requirements.
• Established biocompatibility testing strategies for different cerebral and intrathecal implants in compliance with FDA, Europe, Japan and China regulations, with consideration of available chemical characterization data.
• Remediated non conformities from Notified Bodies on microbiological validations in view of technical files regulatory submissions.