Pioneering Generative AI in Medical Device Development

We don't just advise on regulations — we actively integrate cutting-edge AI/ML strategy into your product roadmap, helping you build smarter diagnostic tools and stay ahead of an evolving FDA landscape.

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Clinical Affairs

From proof-of-concept through randomized trials, our SEC framework gets your product validated efficiently — without breaking the budget. We can help with Proof of Concept, Preclinical Testing, Clinical Trials, and Regulatory Approval.

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Regulatory Affairs

With regulatory environments continually changing, clients depend on our experienced consultants to avoid costly mistakes. We prepare regulatory strategies and submissions for Q-Subs, 513(g), De Novo, 510(k), PMA, IDE, and Technical Files.

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Quality Assurance

From QMS/SOP development to mock FDA audits, we handle every aspect of quality compliance. One of our consultants is a former FDA investigator — giving you an insider's edge on inspections, CAPA, and regulatory submissions.

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