Navigate FDA pathways with confidence. From pre-submission strategy to 510(k) clearance, we deliver hands-on regulatory execution—without the enterprise overhead.
Most medical device companies don't need a full regulatory department—they need strategic guidance and practical execution when it matters. We provide regulatory consulting for medical devices across the entire FDA pathway, from early-stage planning through post-market compliance. Whether you're preparing your first 510(k) submission or navigating a De Novo classification, we deliver the expertise you need without the enterprise price tag.
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Complete 510(k) preparation and submission support, from predicate identification to FDA response management.
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Early-stage regulatory pathway planning to set your device up for success from day one.
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CE marking, Health Canada, and other international regulatory submissions for global market access.
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Ongoing regulatory support to maintain compliance after clearance and throughout commercialization.
We don't just write regulatory documents—we guide you through the entire FDA process with hands-on support at every stage.
We evaluate your device, identify the regulatory pathway, and map out timeline and requirements.
Develop submission strategy, predicate analysis, and document outline with clear milestones.
Complete document preparation, technical writing, and submission packaging ready for FDA review.
Manage FDA interactions, respond to questions, and guide you through clearance and beyond.
FDA-ready submission documents including device description, substantial equivalence, testing summaries, and labeling.
Clear regulatory roadmaps with pathway recommendations, timeline projections, and milestone tracking.
Q-Sub materials including meeting requests, background documents, and specific questions for FDA feedback.
Device Master Files, Design History Files, and technical summaries that meet FDA requirements.
Professional responses to FDA questions, deficiencies, and additional information requests.
Post-market compliance tools including MDR procedures, annual reporting templates, and change control guidance.
We move at startup speed. No 50-page reports—just clear next steps and hands-on document preparation.
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Your regulatory submissions are handled by experienced regulatory professionals, not junior associates learning on your dime.
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Fixed-fee and fractional options designed for lean teams. Know exactly what you're paying before we start.
Whether you're planning your first 510(k) or scaling to commercialization, let's talk about what you actually need.
Book a Discovery CallPractical, plain-English guides written for lean device teams.
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