Frédéric Cadoret joined NAMSA in 2019 to provide expertise in microbiology and to support medical device manufacturers in microbiological evaluations and submissions to Notified Bodies. He has extensive experience in reprocessing validation projects for reusable devices and bioburden, sterility and endotoxin strategies and testing for single-use devices. In addition, it is worth highlighting his experience in conducting training sessions to manufacturers on microbiology according to ISO 11737, 17664, 17665 and AAMI ST98. He holds a PhD in microbiology, vegetal biology and biotechnology.

CORE COMPETENCIES

• More than nine (9) years of professional experience in microbiology in vitro testing
• Conducting training sessions to manufacturers on microbiology according to ISO 11737, 17664, 17665 and AAMI ST98
• Providing multiple consulting services to manufacturers with reprocessing validation projects (i.e. strategy design, Instruction For Use [IFU] review, protocols) for both single-use and reusable devices to submit to the FDA or for CE mark applications
• Assisting manufacturers with developing appropriate bioburden, sterility and endotoxin strategies and testing for single use devices
• Lecturing to Master’s degree students at the Université de Montpellier, Sciences Pharmaceutiques et Biologiques
• Developing new microbiological testing methods

RECENT PROJECTS

• Optimized validation strategies for multiple critical medical devices requesting cleaning and sterilization testing in compliance with European and U.S. requirements
• Optimized testing method to analyze protein residual marker
• Developed testing procedure to validate disinfection efficacy of a reusable medical device
• Optimized the testing procedure for cleaning validation to be compliant with the newly published standard AAMI ST98