J&B Consulting
FDA Medical Device Registration Consulting
Entering the U.S. medical device market requires more than innovation—it demands full compliance with FDA regulations. Our consulting services are tailored to help manufacturers, importers, and distributors navigate the complex FDA medical device registration process efficiently and confidently.
Establishment registration & device listing (FURLS system) – Class I, II, III
510(k), De Novo, or PMA preparation and submission
Labeling and UDI compliance support
Device classification & product code determination
U.S. Agent services for foreign manufacturers
Quality system guidance (21 CFR Part 820) & mock inspections
Who Needs This Service?
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Class I, II, and III device manufacturers
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OEM/ODM and contract manufacturers
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Startups and international device companies entering the U.S. market
Why Choose Us?
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Extensive experience with FDA medical device submissions
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Proven track record in successful 510(k) clearances
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One-stop support from strategy to registration and inspection readiness