Cyber Compliance Landscape for Medical Devices

Medical device manufacturers must navigate multiple regulatory frameworks, such as IEC 62304, ISO 14971, IEC 81001; each addressing different risk domains.

However, these frameworks do not fully cover post-market cybersecurity monitoring, SBOM management across all digital elements, and continuous vulnerability handling in the way required by CRA.

The Cyber Resilience Act (CRA) fills these gaps by imposing cybersecurity obligations across the entire digital ecosystem of the medical device.

Why CyberWhiz for Medical Device Cyber Compliance

While existing medical regulations focus primarily on patient safety and clinical risk, the Cyber Resilience Act (CRA) introduces explicit cybersecurity obligations for products with digital elements.

This means that even when a medical device complies with medical-specific regulations, its digital elements, including software, mobile applications and cloud services must independently meet CRA cybersecurity requirements.

CyberWhiz enables medical device manufacturers to address this regulatory gap by providing end-to-end cybersecurity capabilities aligned with CRA, without interfering with medical safety or clinical compliance processes.

CRA and "Products with Digital Elements" in Medical Devices

Under CRA, medical devices are treated as products with digital elements, meaning:

• Embedded device software
• Companion mobile applications
• Cloud backends and digital services
• Third-party and open-source software components

are all in scope.

CRA introduces requirements for:

• Secure-by-design and secure-by-default development
• Continuous vulnerability handling
• Incident reporting and coordination
• Mandatory SBOM management (Annex I – Part 2, from September 2026)

These requirements apply in parallel to existing medical regulations.

End-to-End Cybersecurity Capabilities for Medical Devices

Embedded Device Security – CyberWhiz Embedded

With CyberWhiz Embedded, we support:

• Secure boot and firmware integrity
• Secure software update mechanisms
• Cryptographic protection and device identity
• Secure communication interfaces

All aligned with CRA cybersecurity principles and compatible with medical device development processes.

Mobile Application Security & SBOM Management – CyberWhiz Mobile

Many medical devices rely on mobile applications for configuration, monitoring and data access.

With CyberWhiz Mobile, we:

• Secure mobile applications used in medical ecosystems
• Protect sensitive data and device control functions
• Align mobile applications with CRA digital element requirements

SBOM Management for Mobile Applications

CRA Annex I – Part 2 (September 2026) mandates:

• Maintenance of accurate Software Bills of Materials (SBOMs)
• Transparency of third-party and open-source components
• Continuous vulnerability assessment

CyberWhiz Mobile enables structured SBOM generation and management for mobile applications, supporting CRA compliance.

Continuous Monitoring & SBOM Management

CyberWhiz Defence Center

CRA requires manufacturers to maintain post-market cybersecurity oversight.

With CyberWhiz Defence Center, we enable:

• Continuous visibility of cybersecurity risks
• Centralized vulnerability tracking
• Incident management workflows aligned with CRA

Unified SBOM Management Across Digital Elements

CyberWhiz Defence Center allows centralized management of SBOMs covering:

• Embedded firmware
• Mobile applications
• Cloud services

Supporting traceability, vulnerability correlation and regulatory reporting.

Red, Blue and Purple Team Support for CRA Readiness

Red Team – Security Assessment Support

• Structured security testing aligned with CRA risk assessment needs
• Identification of technical cybersecurity risks across digital elements

Blue Team – Secure Architecture Design Support

• CRA-aligned security architecture guidance
• Secure update, communication and identity management designs

Purple Team – CRA Risk Assessment & Documentation

• CRA risk assessments
• Technical documentation aligned with CRA Annex I requirements
• Support for regulatory readiness and audits

One Partner for CRA Cyber Compliance in Medical Devices

CyberWhiz provides:

✓ Cybersecurity capabilities aligned with CRA
✓ Coverage of digital elements beyond medical-specific regulations
✓ Structured SBOM and post-market cybersecurity management

CyberWhiz supports medical device manufacturers in addressing CRA cybersecurity obligations while remaining aligned with existing medical regulatory frameworks.

Ready to Achieve CRA Compliance for Medical Devices?

Let's discuss how CyberWhiz can help secure your medical devices end-to-end.