In 2002 David Makanani and Steve Ford, saw an opportunity to use their over 60+ years of combined experience in medical device development, to help companies successfully create products, move swiftly and accurately through the regulatory process and achieve market introduction in the shortest amount of time. OMEDtech was founded in that year to provide a resource with a proven track record of success to assist your company in meeting its product development goals.
With many years of US and International medical device experience, OMEDtech has played key roles in bringing a number of diverse medical devices from concept to market. This experience includes product development, design control, clinical trials, regulatory strategies, the full range of Quality Systems Regulation (QSR) and compliance activities, and the creation of operations and manufacturing for a number of startup companies. Products for which approvals have been received include heart valves, pacemakers, neurostimulators, infusion pumps and IV administration products, implantable hearing systems and a number of other related products.