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Services

Expert Services for Every Stageof Device Security

From the MShield Platform to FDA audit representation — MShield's expert team works alongside your engineers and regulatory leads to close gaps, accelerate submissions, and defend your program.

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End-to-End Coverage

MShield Platform

Continuous cybersecurity integration across your full device lifecycle — R&D, verification, market release, and post-market surveillance — mapped to FDA and EU MDR requirements.

Explore the MShield Platform
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Regulatory

FDA Submissions Support

Expert review of your 510(k), De Novo, or PMA cybersecurity documentation. Upload your existing files for a free preliminary review by our regulatory team.

Get a Free Review
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Assessment

Security Testing & Posture Review

Upload your existing security posture assessment for a structured gap analysis against IEC 62443, NIST SP 800-30, and FDA cybersecurity guidance. Receive a prioritized remediation roadmap.

Submit for Review
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Representation

FDA Submissions & Audit Representation

Direct representation during FDA pre-submission meetings, deficiency responses, and on-site audits. Our team prepares your documentation and stands alongside you through every regulatory interaction.

Engage Our Team

Not Sure Which Service Fits?

Request a discovery call and we'll map the right engagement to your device program and timeline.

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