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<h3>Reach Out to Our Experts</h3> <p>Contact Reglumina Partners for medtech startup compliance consulting in Irvine, California.</p>

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Partner with Reglumina Partners to navigate FDA cybersecurity submission readiness for your medical devices. Our expert team in Irvine, CA, is ready to guide your compliance journey.

Ensure Compliance Success Today

Reglumina Partners

My business is a consulting firm that helps medtech startups avoid losing months of runway to preventable FDA submission delays—especially delays caused by cybersecurity requirements under FD&C Act Section 524B. We work with connected medical device and SaMD teams preparing 510(k) or De Novo submissions to build the exact “cyber packet” FDA reviewers expect: SBOM, threat modeling, cybersecurity risk assessment, vulnerability disclosure and monitoring plan, patch/update strategy, security architecture documentation, and traceability. The result is a coherent, reviewer-ready package that reduces back-and-forth and keeps approval timelines predictable.

Hanken Grotesk

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