About Us
Medical Device Design and Development
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Cambridge Medical Devices has been developing medical devices and instrumentation for over 25 years, specializing in ultra rapid product development under FDA design controls. Our development team has experience in industrial design, electronics, software, mechanical design, injection molding, fluidics, optics, system integration, DFM, value engineering, and project management.
Ultra Rapid Product Development
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CMD is expert at applying ultra rapid product design and development practices to medical devices. These tools, created at Stanford, Apple, MIT, Toyota, and General Motors focus on a "fail fast" methodology. CMD has perfected a set tools and processes that rapidly ensure design viability before investing in engineering and manufacturing tooling.
CMD's Fullerton office has full rapid prototyping capability including CNC milling, lathe, fabrication tools, 3D printing, electronics build and test, and microfluidics testing. CMD's long term relationships with component vendors and contract manufacturers allows our clients to get to market quickly with high quality.
Compliance Consulting
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CMD has experience creating and remediating DHF for new and existing medical devices, and specifically upgrading life sciences and RUO instrumentation to IVD compliance. Class I and II devices, 510(k) and PMA.
Our Team
President / Product Design
Michael White
Systems Design / Fluidics
Omar Abdallah
Operations / Program Management
Jeffrey Ho
Electrical Engineering / Firmware
Jeff On
Manufacturing / DFM
James Gearhart
Product Development Intern (UCLA Bioengineering)
Elizabeth Williams
Partners
Gordon Grajek CEO / Mechanical Design
Phu Quach CTO / Design / Systems / Analysis
Dave Hines / Industrial Design