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 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 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 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 reusable medical device.
• Optimized the testing procedure for cleaning validation to be compliant with the newly published standard AAMI ST98.