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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Strategic · Agile · Aligned
Pulse Axis Medical Device Consulting
Regulatory strategy, quality systems, and FDA submissions for Class I & II medical devices and diagnostics.
Quality Systems & Compliance
QMS development, gap assessments, internal audits, remediation, and FDA readiness preparation.
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Formative & summative usability testing protocols and documentation for safer, intuitive devices.
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