Every device update triggers a compliance event. EVSec turns your 524B package into a living system.
Real-time threat analysis. Context-aware compliance. Always audit-ready, from FDA submission through continuous postmarket surveillance.
- 524B package auto-updated in 4 hours vs. 3 weeks manually
Every software update to a device is a compliance event
Static tools weren’t built for devices that update continuously. Every software release, every new CVE, every supplier component change reopens your 524B obligation.
- FDA Section 524B requires SBOM and vulnerability management. Postmarket surveillance is mandatory, not optional.
- A missed CVE isn’t just a compliance gap. It’s a potential recall, FDA warning letter, or 510(k) rejection.
- Static compliance tools force a choice: ship fast or stay compliant. EVSec eliminates that trade-off.
Why traditional approaches fail
Competitors give you point-in-time compliance snapshots. EVSec gives you a living 524B package that updates itself.
C2A unifies threat modeling, SBOM intelligence, and vulnerability monitoring into a single AI-driven flow
Continuously updated security for medical devices
Continuous model: the core differentiator
New CVE disclosed? The 524B package updates automatically: threat model, SBOM impact, compliance docs, version control. No manual restart.
SBOMs ingested
Device components, third-party libraries, and supplier software are tracked continuously across the full device architecture.
Vulnerabilities correlated
CVEs are matched to specific device components: clinical impact, device usage context, and patient risk are all factored in.
AI risk analysis
Risk is ranked by real device impact, not generic CVSS. Clinical context, operational environment, and 524B obligations are automatically assessed.
Prioritized remediation
Engineering directed to what actually matters for patient safety: every prioritized fix is tracked against 524B documentation automatically.
Real-time threat analysis. Context-aware compliance. Always audit-ready.
Engineering on high-impact issues
Teams focus on vulnerabilities with real clinical impact, not generic CVE triage.
FDA readiness, always
Structured 524B documentation updated automatically, never manually rebuilt before submission.
Postmarket surveillance automated
Every device update triggers continuous vulnerability re-assessment and documentation refresh.
Legacy installed base stays covered
Already-deployed devices stay covered; legacy SBOMs update automatically when new CVEs emerge against installed components.
Built for every medtech compliance framework
- Built to turn regulatory requirements into automated workflows. Compliance is continuous, not a pre-submission scramble.
- Start with SBOM and vulnerability management. Scale to full 524B orchestration as your program matures.
FDA Section 524B
FDA premarket guidance
IEC 62443
NIST CSF
“C2A Security probably has the best threat analysis tool in the market, which also allows for streamlined collaboration between internal and external stakeholders.”
"The method of integration between the BOM information and the TARA is a unique differentiator of EVSec, something we haven’t seen with other vendors."
"At Elekta, we’re committed to providing safe, resilient solutions to our customers. Our collaboration with C2A Security will enable us to integrate cybersecurity throughout our product portfolio, helping us meet compliance requirements while keeping our systems secure."
"We believe this integration with C2A Security will be a milestone in product cybersecurity automation and vulnerability management, aiming to better comply with UN Regulation No. 155, ISO/SAE 21434 standards, among others."
"Thank you for this great product and your work!"
"That's a very cool risk management product you've got there, exactly what we need, and I haven't seen that before."
"This is a powerful tool for any company to have, and we’re excited about the collaboration with C2A Security and the value it can bring to our customers."
"C2A Security shares the same vision as MIH, in offering a seamless and holistic approach to automotive cybersecurity over the entire lifecycle."
"Fuzz testing, with C2A Security's solution, enables early discovery of vulnerabilities hence reducing the time needed to deliver SW and products."
"We want to apply our expertise in cybersecurity to the connected car sector. Thanks to our global Automotive Security Test Center and to our collaboration with C2A Security, NTT DATA will be an international reference point to protect connected cars from cyber-attacks and ensure the drivers' safety."
"We have deeply felt the growth of the intelligent connected vehicle business and cybersecurity is an indispensable part of the intelligent connected vehicle. The cooperation with C2A Security provides cybersecurity solutions for the whole lifecycle of connected vehicles in China. We look forward to expanding the cooperation globally and bringing the vehicle industry to a safer future."
"C2A Security is the future of cybersecurity, and with their technologies to automate security, together we will go further in monitoring, preventing risk, identifying and mitigating vulnerabilities."
Secure medical devices with context-aware AI risk prioritization
Live risk intelligence. Continuous 524B compliance. Always audit-ready.
