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.

ARE YOU SEEKING FDA CLEARANCE?

For over 20 years, we have helped thousands of medical device, biologic, and in vitro diagnostics companies gain FDA approval. Smith Associates can help you successfully prepare for Quality System Compliance, FDA Inspection, Human Factor Studies, 510k Clearances, 510k Approvals, 483 Observations & Warning Letter Response.
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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.

OUR SERVICES

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.