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.
- 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.
- 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.