Medical Device Security Testing & VA/PT for IEC 60601 Compliance | Cyber Risk Assessment in United States

Overview

Medical electrical devices in the United States are increasingly connected, software-driven, and integrated with hospital networks. While this digital transformation improves efficiency and patient outcomes, it also introduces cybersecurity risks that can impact patient safety, essential performance, and regulatory compliance.

IEC 60601 defines the global safety and essential performance requirements for medical electrical equipment. As cybersecurity threats can disrupt alarms, control functions, and device reliability, Vulnerability Assessment (VA) and Penetration Testing (PT) are critical to ensure devices are safe and compliant.

Cyberintelsys, a CREST-accredited cybersecurity company, provides specialized IEC 60601 VA/PT services in the United States, helping manufacturers identify risks, test device security, and demonstrate compliance readiness.

Why VA/PT Matters for IEC 60601 Devices in the US?

Cyber risks affecting medical electrical equipment can lead to unsafe operation, service disruption, or loss of sensitive patient data. Structured VA/PT supports:

  • Patient safety protection: Detects cyber risks impacting essential performance

  • Regulatory preparedness: Aligns with FDA, IEC 60601, and hospital cybersecurity expectations

  • Risk-based decision making: Integrates cybersecurity into safety and quality processes

  • Market acceptance: Strengthens trust with hospitals, distributors, and procurement teams

  • Lifecycle security: Supports secure design, deployment, and post-market surveillance

Cyberintelsys IEC 60601 VA/PT Approach

1. Vulnerability Assessment (VA)

  • Automated scanning of firmware, software, and network interfaces

  • Manual review of configurations and access controls

  • Assessment of third-party dependencies and APIs

  • Documentation of vulnerabilities and CVSS scoring

Deliverables: VA report with severity, impact, and remediation guidance.

2. Penetration Testing (PT)

  • Network and device exploitation tests

  • Wireless communication testing (Wi-Fi, Bluetooth, IoMT)

  • Mobile app, API, and cloud interface security testing

  • Proof-of-concept attack demonstrations in controlled environments

Deliverables: PT report showing exploitable vulnerabilities without affecting device operation.

3. Risk Analysis & Prioritization

  • Evaluation of vulnerability impact on patient safety and regulatory compliance

  • Prioritization of remediation actions based on severity and likelihood

  • Integration into secure development lifecycle (SDLC)

4. Reporting & Compliance Documentation

  • CREST-aligned reports for internal review or regulatory submission

  • Gap analysis referencing IEC 81001-5-1, ISO 14971, and NIST

  • Actionable remediation recommendations

Key Benefits of Cyberintelsys Services

  • Enhanced patient safety: Early detection of cyber risks impacting medical devices

  • Regulatory assurance: Aligns with IEC 60601, FDA, and hospital standards

  • CREST-accredited expertise: Trusted, globally recognized methodology

  • Operational resilience: Ensures device reliability in clinical environments

  • Continuous improvement: Supports integration of findings into ongoing cybersecurity governance

Medical Electrical Devices Covered

Cyberintelsys provides VA/PT services for a wide range of IEC 60601 medical electrical devices, including:

  • Patient monitoring and life-support systems

  • Infusion and therapeutic devices

  • Diagnostic and imaging equipment (MRI, CT, Ultrasound)

  • Wearable and IoMT-enabled devices

  • Hospital-integrated and network-connected systems

Why Choose Cyberintelsys in the US?

  • CREST-accredited cybersecurity company with proven expertise

  • Experience with IEC 60601, IEC 81001-5-1, ISO 14971, and NIST frameworks

  • Understanding of US healthcare ecosystem and FDA expectations

  • Audit-ready, actionable reporting

Conclusion

For medical device manufacturers in the US, IEC 60601 VA/PT is essential to ensure cybersecurity, patient safety, and regulatory compliance.

Cyberintelsys helps organisations:

  • Identify and remediate vulnerabilities in medical electrical devices

  • Strengthen compliance readiness and patient safety

  • Integrate cybersecurity into risk management and SDLC

  • Build confidence with hospitals, regulators, and healthcare providers

Cyberintelsys – your trusted IEC 60601 VA/PT and medical device security assessment partner in the United States.

Reach out to our professionals

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