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Strategic · Agile · Aligned

CoActiV Medical Device Consulting

Regulatory strategy, quality systems, and FDA submissions for Class I & II medical devices and diagnostics.

CoActiV — regulatory strategy meeting with cross‑functional device team
Replace with hero banner — device lab or team workshop.

Regulatory Strategy & Submissions

510(k), De Novo, Q‑Subs, 513(g), STeP, Breakthrough, and more—tailored to your product and timelines.

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Quality Systems & Compliance

QMS development, gap assessments, internal audits, remediation, and FDA readiness preparation.

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Human Factors Engineering

Formative & summative usability testing protocols and documentation for safer, intuitive devices.

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