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About Us

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.

What We Offer

1
From requirements definition to design verification testing, our services can cover the complete product development cycle.
2
High-level architecture, system partitioning, and operational flow, with risk management and mitigation considered at every step.
3
Breaking down any development into manageable pieces, while reliably adhering to cost, schedule, and performance targets.

Our Staff

Ronald Scharf, PhD
Founder & CEO
Dr. Scharf holds advanced degrees in Electrical Engineering from the University of Erlangen, Germany, and Business Administration from the University of California at Berkeley's Haas School of Business.