From early-stage strategy to FDA submission and beyond. Independent consulting that moves your device forward without the overhead of a large firm.
We support medical device companies across the full product lifecycle from first concept to global market access.
FDA 510(k), PMA, De Novo, EU MDR, and major global markets. Pre-submission meetings, predicate analysis, and full submission preparation.
Learn moreTest planning, bench testing, usability, software validation, sterilization, and process validation designed to pass first-time review.
Learn moreISO 13485, QMSR (21 CFR 820), audit prep, CAPA, supplier quality built for your stage and complexity.
Learn moreISO 14971 risk files, IEC 62366 usability engineering, FDA human factors submissions, and combination product risk strategies.
Learn moreSaMD regulatory strategy, IEC 62304, AI/ML PCCP, cybersecurity submissions, SBOM, and IoMT architecture review.
Learn moreCER, IDE applications, ISO 14155 clinical investigations, PMCF studies, and real-world evidence strategy.
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Seed through Series A companies building their first device and navigating FDA for the first time
Series B and beyond scaling operations, entering new markets, or expanding indications
Companies facing remediation, enforcement response, or launching next-generation products
Regulatory and quality due diligence for M&A transactions and technical investment reviews
Not a junior consultant managed by a senior one. Every engagement is handled by someone with deep hands-on experience across regulatory, quality, and clinical functions.
The right regulatory path, predicate, and quality system from the start saves more time and money than any submission shortcut. We build the strategy first.
Whether you are a two-person startup or an established manufacturer, the approach is calibrated to your complexity not a one-size-fits-all methodology.
A free 20-minute call is enough to point you in the right direction whether you become a client or not.
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