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OMEDtech, provides quality system design, regulatory, compliance, clinical and operations consulting services that are focused on helping managers and companies meet the aggressive challenges of bringing new medical device products to market.
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MDUFA III Guidance Documents Final Release
FDA released three MDUFA III guidance documents on 12/31/2012. Happy New Year! The guidance documents discuss key provisions of MDUFA III. The guidances are on the eCopy program, Premarket Approval Applications and 510(k) files acceptance criteria. For a little light reading, check out this link.
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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 [...]
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