Preclinical Scientist with proven success helping medical device companies develop concepts for regulatory approval and production. Fundamental understanding of medical device development gained through 19 years of experience in the medical device industry developing at least 6 successfully launched medical device products. Expertise includes: • ISO 10993 and FDA Guidance• Medical Device Biocompatibility• Biocompatibility Risk Assessment• Medical Device Stability • Manufacturing Process Development• Equipment Installation and Qualification• Test Method and Specification Development • Management of CRO Relationships
Listed skills include Medical Devices, Fda, Capa, Design Control, and 28 others.