Smith Associates is a highly experienced and successful medical device regulatory consulting firm based in Crofton, MD. With over 20 years of expertise in FDA compliance, they specialize in assisting medical device, biologic, and in vitro diagnostics companies in gaining FDA approval. Their services include regulatory submissions, quality system compliance, human factor studies, and 510k clearances.
With a team of consultants who have extensive backgrounds in FDA regulatory affairs and sales marketing, Smith Associates understands the financial pressures and marketing needs of businesses. They have achieved over 280 successful 510k clearances and offer fixed fees for their consulting services, ensuring transparency and no surprises. Located just 20 minutes from the FDA, they hand-deliver all submissions and responses to the Document Room for efficient processing.
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