End-to-end 510(k) consulting built for MedTech companies that can't afford to wait. We've cleared hundreds of devices — and we know exactly how to get yours through on the first submission.
Most firms hire general regulatory consultants. We only do 510(k). That narrow focus means deeper expertise, tighter timelines, and fewer surprises from FDA reviewers.
We know what FDA reviewers look for because some of us were FDA reviewers. Insider knowledge means we anticipate deficiencies before they become AI letters.
We don't split attention between IND, BLA, and PMA work. Every protocol, template, and checklist we've built is purpose-engineered for the premarket notification pathway.
Over 20 years of cleared submissions catalogued. We surface the strongest, most defensible predicates fast — and build your substantial equivalence argument around them.
No billable-hour surprises. You get a clear scope, a firm price, and a dedicated lead consultant — not a revolving door of junior staff.
We build your submission directly in FDA's eSTAR template from day one, eliminating the costly re-formatting step that delays most submissions by weeks.
We don't hand you a submission and disappear. We manage all FDA correspondence — AI requests, clarifications, and interactive review — through clearance.
Device classification, pathway selection, and pre-submission planning designed to avoid surprises and minimize review time.
Get started →Deep-dive comparative analysis across cleared devices, substantial equivalence strategy, and predicate chain documentation.
Get started →End-to-end eSTAR preparation — device description, labeling, testing summaries, biocompatibility, performance data, and all required sections.
Get started →We draft and manage your Pre-Sub meeting request, prepare briefing documents, and coach your team for the FDA discussion.
Get started →Already received an AI request or Refuse-To-Accept? We rapidly assess, remediate, and resubmit to get you back on track.
Get started →Software as Medical Device and AI-enabled devices require specialized strategy. We navigate evolving Digital Health Center of Excellence guidance.
Get started →A streamlined five-step engagement designed to eliminate ambiguity, hold your timeline, and get your device to market.
Free 30-min assessment of your device, classification, and fastest pathway.
Fixed-fee proposal, timeline, milestones, and a named lead consultant.
Predicate selection, testing strategy, Pre-Sub meeting if needed.
Full eSTAR build with multi-pass QC and client sign-off.
We submit, manage FDA correspondence, and see you through to SE determination.
Book a free 30-minute strategy call. We'll assess your device, identify your pathway, and give you a clear picture of what clearance takes — no obligation.
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