Cambridge Medical Devices has been developing medical devices and instrumentation for over 20 years, specializing in ultra rapid product development under FDA design controls.
CMD is expert at applying ultra rapid product design and development practices to medical devices. These tools, created at Stanford, 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 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.