For over 20 years, we have been living and breathing Medical Device Development in all of its various forms: diagnostic, therapeutic, capital equipment, disposables, or drug/device combinations, just to name a few. We can offer service and support throughout the complete product development process: market definition; IP landscape evaluation; regulatory requirements analysis; user needs and design inputs definition; feasibility demonstration; systems engineering; architecture, subsystem, and detailed design; engineering confidence and design verification testing; and preparation of documentation packages for regulatory submission in the US and Europe.