Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood products and combination products. Our mission statement of affordable fees for regulatory compliance remains in place and has resulted in the launch of hundreds of start-ups companies into the medical device market.
SUBMISSIONS TO THE FDA - Smith Associates has extensive experience in all aspects of the regulatory processes of 510(K), PRE-SUB, IDEs and PMA/BLA submissions. Our successes with 510(k)s, PMA, and IDEs, are summarized in Projects.
Smith Associates is located 20 minutes from FDA enabling quick response to FDA during interactive reviews.
HUMAN FACTORS/USABILITY STUDIES are playing a larger role in validating usability and label comprehension in the design development process and also in 510k submissions. Please see Human Factors for our comprehensive services and visit our Human factors page on facebook.
QUALITY SYSTEM COMPLIANCE services includes complete and Implement-ready Part 820 cGMP Quality System, which is available for all size companies and classifications and with price that will fit your budget.
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