Smith Associates

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Crofton, MD 21114
+1 (888) 729-9674
http://www.fdaconsultants.com

Smith Associates, based in Crofton, MD, has specialized in medical device regulatory affairs for over 20 years, assisting companies in navigating the complexities of FDA compliance, including 510(k) submissions, PMA, and IDE applications. Their team boasts extensive experience and a successful track record, having achieved more than 280 clearances across various regulatory branches.

The company offers a transparent, fixed-fee structure for its consulting services, ensuring clients are informed throughout the submission process without unexpected costs. With a focus on both regulatory and marketing aspects, Smith Associates aims to help clients effectively position their products in the competitive medical device market while maintaining compliance with FDA requirements.

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