We design, document, and implement your Secure Product Development Framework for 510(k), De Novo, PMA, and IDE submissions - aligned with FDA Section 524B, AAMI SW96, IEC 81001-5-1, and ISO 14971.
The short answer
Secure-by-design means building cybersecurity into a medical device from the first architecture decisions rather than adding it before submission. In practice it follows a Secure Product Development Framework (SPDF): security requirements, threat modeling during design, secure coding and component choices, and testing that proves the controls work. Starting early is cheaper than redesigning late, and it produces the evidence the FDA's 2026 guidance asks for.
275+ devices supported · 100% Deficiency Commitment
Section 524B of the FD&C Act now requires a Secure Product Development Framework for all 'cyber devices.' FDA reviewers expect to see the artifacts, not promises - and most teams aren't ready.
FDA cybersecurity deficiencies routinely add 3-6 months to clearance timelines. For a $20M/year device, that's $1.5M+ in lost revenue, plus burn and investor pressure.
Per FDA premarket cybersecurity guidance, missing or weak SPDF documentation is one of the top reasons reviewers send deficiency letters or refuse-to-accept (RTA) determinations.
Without an SPDF, vulnerabilities slip into production - leading to recalls, MedWatch alerts, lawsuits, and brand damage you can't undo.
Aligned to the FDA's February 2026 cybersecurity guidance: an SPDF is one way to satisfy the QMSR (21 CFR 820 / ISO 13485:2016) - it's an integrated process, not a single document. We deliver every piece.
Most cybersecurity cost on a medical device is decided before the first prototype boots. The engagement covers the architectural and process decisions that determine whether the device clears §524B cleanly or fights deficiencies for years.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Most vendors put you in a 4-to-8-week onboarding queue. We start this week.
Talk directly with a senior MedTech security practitioner. We learn your device, submission timeline, intended use, and risk profile. No sales reps, no qualification gauntlet.
We map your current state against FDA 524B, AAMI SW96, and IEC 81001-5-1, then deliver a fixed-fee scope, deliverables list, and timeline. No T&M, no scope creep.
We embed with your engineers, run threat modeling workshops, generate SBOMs, perform pen testing, and produce every required artifact - in your QMS, on your tools.
Cybersecurity Risk Management Report, threat model, SBOM, security architecture views, pen test report, and labeling - eSTAR-formatted and backed by our remediation commitment.
Every secure medtech product design engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
Section 524B treats updateability as a design-input requirement, not a postmarket aspiration. Devices designed without a defensible update channel cannot retrofit compliance - reviewers require redesign.
We design, document, and implement your Secure Product Development Framework for 510(k), De Novo, PMA, and IDE submissions - aligned with FDA Section 524B, AAMI SW96, IEC 81001-5-1, and ISO 14971.
