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CRA compliance begins Sept 11. Are you ready? We'll show you how.
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Use Case: Compliance Management

Compliance that keeps pace with your product and business needs.

Regulations change. Products update. CVEs land. Static compliance packages fall behind the moment they are submitted. EVSec maintains living compliance documentation that adapts automatically, across every framework you operate under.

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Regulatory frameworks supported in a single platform

Dynamic
Compliance documentation regenerated when product or regulation changes

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Manual steps to produce a submission-ready report from live data

Continuous
Compliance status maintained, not just assessed at audit time
The Challenge

Your compliance package is out of date before it reaches the regulator

Every product update restarts the compliance process

New software version, new component, new supplier. Each change requires manual re-validation of your entire compliance posture.

Multiple frameworks multiply the burden

UN R155, FDA 524B, EU CRA, ISO/SAE 21434. Each requires separate documentation assembled by hand with no shared data source.

Gap analysis is a one-time exercise

Compliance gaps identified in an audit are fixed for that audit. Without continuous monitoring, new gaps appear undetected between submissions.

Audit preparation consumes weeks of engineering time

Assembling evidence, mapping requirements to controls, generating reports. All manual, all repeated every cycle.

Why Traditional Approaches Fail

Competitors generate compliance reports
EVSec maintains living compliance data flows

Capability
Traditional
EVSec
Compliance status
Point-in-time assessment, manual re-run
Continuous validation, updated automatically
Multi-framework support
Separate tools or manual mapping per framework
UN R155, ISO/SAE 21434, FDA 524B, EU CRA, IEC 62443 in one platform
Response to product change
Manual re-validation required
Compliance documentation regenerated automatically
Gap identification
Periodic audit finding
Continuous gap monitoring with remediation guidance
Report generation
Manual assembly for each submission
Submission-ready reports generated on demand from live data
Compliance intelligence
Raw audit data, interpretation left to engineers
Actionable intelligence connecting requirements, evidence, and gaps into prioritized decisions
How It Works

From regulatory requirement to a living compliance package

1. Define
2. Map
3. Validate
4. Adapt
5. Submit
Regulatory frameworks selected and decomposed into requirements. Pre-built catalogs for all major standards.
Requirements mapped automatically to your product model, controls, and security evidence.
Compliance status checked continuously. Gaps surfaced with remediation recommendations.
Product change or regulation update triggers automatic re-validation. No manual re-run required.
Submission-ready reports generated on demand. UN R155, ISO/SAE 21434, FDA 524B, EU CRA, and more.
Key Capabilities

Every regulation, one living compliance system

Multi-framework compliance
UN R155, ISO/SAE 21434, FDA 524B, EU CRA, IEC 62443, NIST, and more. All managed from a single data source with cross-regulation mapping.
Module:EVSec Compliance Center
Continuous compliance validation
Compliance status checked automatically as your product evolves. Gaps identified in real time, not at audit time.
Module:EVSec Compliance Center
Auto-generated regulatory reports
Submission-ready documentation generated on demand. Coverage reports, gap analyses, and maturity assessments produced automatically.
Module:EVSec Compliance Center
Cross-regulation mapping
Requirements mapped and compared across frameworks. Meet multiple regulations simultaneously without duplicating effort.
Module:EVSec Compliance Center
Workflow automation
Compliance processes automated end to end. Evidence collection, control validation, report generation triggered without manual coordination.
Module:EVSec Workflow Automation
AI-powered gap analysis and compliance intelligence
AutoSynth AI identifies compliance gaps, recommends remediation steps, and predicts risk before it becomes a finding.
Module:EVSec AutoSynth AI & MCP Services
Frameworks

UN R155

UN R156

ISO/SAE 21434

FDA 524B

EU CRA

IEC 62443

NIST SSDF

ISO 14971

AIS 189

Auto-ISAC ATM

ENISA

DORA

GB 44495-2024

GB 44496-2024

NIS2

“C2A Security probably has the best threat analysis tool in the market, which also allows for streamlined collaboration between internal and external stakeholders.”

Risk Management Lead, Product Security
Fortune100 Consultancy Firm

"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."

Fortune100 Consultancy Firm
US Tier 1 Supplier

"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."

John Chenoweth
Chief Product Security Officer, Elekta

"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."

Tin N.
Director

"Thank you for this great product and your work!"

Joachim Bozler
Senior Security Expert

"That's a very cool risk management product you've got there, exactly what we need, and I haven't seen that before."

European OEM
CISO

"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."

Piyush Karkare​
Global Director, Automotive Solutions​

"C2A Security shares the same vision as MIH, in offering a seamless and holistic approach to automotive cybersecurity over the entire lifecycle."

Jack Cheng
CEO

"Fuzz testing, with C2A Security's solution, enables early discovery of vulnerabilities hence reducing the time needed to deliver SW and products."

Cosimo Senni Guidotti Magnani
Global Product Cyber Security Manager

"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."

Marco Garelli
Head of Automotive

"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."

Wenguang Wu
Executive President

"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."

Geoffrey Bouquot
Group Chief Technology Officer & Senior Vice President Strategy

"Our compliance package is a living system, not a static snapshot. When requirements change, the platform adapts. We do not stop shipping to rebuild documentation."

VP Regulatory Affairs

Medical Device Manufacturer

GET STARTED

See EVSec maintain compliance across your product portfolio

Living compliance documentation. Every framework. Always current.
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Speaker Profile

Geoffrey Mann

Senior Physical Threat Analyst

Health-ISAC

Speaker Profile

John Auld

CRO

C2A Security

John Auld serves as Chief Revenue Officer at C2A Security, where he leads the company’s expansion into healthcare following the strategic acquisition of Vigilant Ops. With 20 years of experience bringing together complementary technologies across regulated industries, John specializes in helping manufacturers turn cybersecurity from a compliance burden into a competitive advantage. A mechanical engineer by training with deep expertise in product lifecycle management, John champions Dynamic Risk Management as the bridge between component visibility and actionable intelligence. His mission: enable medical device manufacturers to innovate safely without sacrificing speed or patient safety.

Speaker Profile

Ken Zalevsky

VP and GM, Medical Technology

C2A Security

Ken Zalevsky brings over 20 years of medical device cybersecurity experience to his role at C2A Security, where he serves as VP and GM, Medical Technology, following the acquisition of Vigilant Ops in October 2025. A former Bayer executive, Ken founded Vigilant Ops in 2019 after witnessing the consequences of inadequate technical preparation in the healthcare industry. He is an active contributor to CISA’s SBOM working groups and a frequent speaker on software supply chain security. Ken’s mission: transform SBOM from a compliance checkbox into operational intelligence that keeps patients safe while streamlining regulatory processes.