Carbide Consulting
Biocompatiblity and Materials Services for Medical Devices
Regulatory & Biocompatibility Consulting for Medical Device ManufacturersBiological Evaluation Plans & Reports — Development of biological evaluation plans (BEPs) and reports (BERs) in line with ISO 10993-1, identifying the right testing strategy for your device.Test Program Management — Coordination of testing with accredited labs, from scoping through scheduling to delivery.Test Report Review — Independent review and interpretation of biocompatibility and lab test reports for accuracy, completeness, and regulatory readiness.Ethylene Oxide Sterilization — Support for EtO sterilization validation per ISO 11135, including process understanding and documentation review.Materials Characterization & Sterile Barrier System Testing & Aging — Guidance on sterile barrier packaging testing per ISO 11607, including accelerated and real-time aging studies.Analytical Testing — Experience with SEM, EDS, and other analytical techniques for materials characterization beyond standard ISO 10993 testing.
B.S. Materials Science & Engineering, UC Berkeley — M.Eng. Materials Engineering, University of WaikatoFor almost a deciade, I've worked in the medical device industry, where materials science meets patient safety and regulatory compliance. I built and owned an entire biocompatibility, materials, and sterilization program. From biological evaluation plans and reports to sterile barrier testing, aging studies, and ethylene oxide sterilization validation. I brought devices from early design through regulatory approval and post-market support.I left corporate industry in May 2026 to start Carbide Consulting, bringing that same hands-on ownership to every client I work with.