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510(k) Submissions

Many devices require a 510(k) submission before entering the US market. Our experienced team can guide you through every step, reducing time to approval and minimising regulatory risk.

Predicate Device Strategy: Identify the right FDA product code, regulation number, and predicate device to streamline testing and improve success.
Testing & Data Requirements: Research applicable FDA pathways (Traditional, Special, Abbreviated, Safety & Performance) and define clinical and regulatory requirements.
Gap Analysis: Evaluate your existing documentation against FDA expectations and create a clear gap report.
Compilation & Submission: Complete your 510(k), submit it to the FDA, and handle follow-up queries through to clearance.