Smith Associates Inc of Crofton, MD at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
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Smith Associates Inc

1468 Harwell Avenue, 21114 Crofton, MD
United States of America

Telephone +1 410 4510631
Fax +1 410 7930448
christian.ssmedical@gmail.com

This company is co-exhibitor of
Maryland Department of Commerce

Hall map

MEDICA 2017 hall map (Hall 16): stand C18

Fairground map

MEDICA 2017 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

About us

Company details

Smith Associates, FDA Consultants
Consultants Specializing in Regulatory Affairs for FDA Compliance
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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