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.


Submissions To The FDA

  • 510(k) Submission & Pre-Submission
  • IDE
  • PMA/BLA Submissions
    US Agent Services
    Initial Importer

Human Factors/Usability Studies

  • HF & Design Control
  • HF/Usability & 510k
  • HF/Label Comprehension

Quality System Compliance

  • Quality System SOPs Part 820
  • Quality System Audit
  • 483 & Warning letter Response
  • Recall and Corrections

Why should I choose
Smith Associates for my 510(k)?


There may be many factors in your selection process, but listed below are the most important.

We service all sized companies and classifications within your budget.