ABOUT US 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. This includes the most common route to clearance in the United States, the 510k submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510ks. READ MORE OUR SERVICES Why should I choose Smith Associates for my 510(k)? TOLL FREE 1-888-729-9674 LOCAL 410-451-0639 EMAIL info@fdaconsultants.com ABOUT US 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. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English

MEDICAL DEVICE REGULATORY CONSULTING Smith Associates are consultants specializing in medical device regulatory affairs for FDA compliance and have extensive experience and success in all aspects of the regulatory processes of 510(k), Pre-Submissions, IDEs and PMA/BLA submissions. REQUEST A QUOTE ABOUT US 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. This includes the most common route to clearance in the United States, the 510k submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510ks. READ MORE OUR SERVICES Why should I choose Smith Associates for my 510(k)? TOLL FREE 1-888-729-9674 LOCAL 410-451-0639 EMAIL info@fdaconsultants.com ABOUT US 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. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English