Introduction

Medical electrical devices are increasingly dependent on software, connectivity, and digital interfaces to deliver accurate diagnosis and therapy. While IEC 60601 establishes strict requirements for electrical safety and essential performance, modern cyber threats can undermine these protections by disrupting device operation, manipulating control logic, or disabling safety mechanisms.

For medical device manufacturers in Sweden, Vulnerability Assessment and Penetration Testing (VA/PT) has become a critical activity to demonstrate that cybersecurity weaknesses do not compromise IEC 60601 safety objectives. Cyberintelsys provides specialized medical device security services that combine real-world security testing with IEC-aligned compliance expertise, helping manufacturers achieve safer and certification-ready medical electrical devices.

Why VA/PT Is Essential for IEC 60601 Medical Electrical Devices

Cybersecurity vulnerabilities can introduce indirect safety hazards, even when electrical design requirements are met. Exploitable weaknesses may:

• Interfere with essential performance functions

• Cause unexpected device behavior or shutdowns

• Disable alarms or monitoring features

• Allow unauthorized access to service or maintenance interfaces

VA/PT helps identify these risks before they impact patient safety or regulatory approval.

What Is IEC 60601 Vulnerability Assessment & Penetration Testing?

IEC 60601-focused VA/PT evaluates a medical electrical device’s resistance to cyber threats that could affect safety or performance. Unlike generic IT testing, this approach is safety-aware and aligned with medical device regulations.

Key objectives include:

• Identifying exploitable cybersecurity vulnerabilities

• Demonstrating the effectiveness of security controls

• Validating that cyber attacks cannot compromise essential performance

• Supporting safety and risk management documentation

The results provide actionable insights for remediation and compliance readiness.

Cyberintelsys VA/PT Methodology for Medical Devices

Cyberintelsys applies a structured and standards-aligned VA/PT methodology tailored to medical electrical devices.

Scope Definition Based on Safety Impact

Testing focuses on interfaces and components that influence:

• Power management and control systems

• Software controlling essential performance

• Network, wireless, and remote access points

• Maintenance and service interfaces

This ensures testing remains relevant to IEC 60601 safety requirements.

Vulnerability Assessment

Cyberintelsys conducts in-depth vulnerability identification using:

• Secure configuration reviews

• Software and firmware analysis

• Network and communication testing

• Authentication and access control evaluation

Identified vulnerabilities are prioritized based on potential safety impact.

Penetration Testing

Penetration testing simulates realistic attack scenarios to:

• Validate exploitability of vulnerabilities

• Assess effectiveness of existing security controls

• Evaluate the potential impact on device operation and safety

Testing is performed safely, without disrupting clinical use.

Alignment with Key IEC and Medical Device Standards

Cyberintelsys ensures VA/PT findings are mapped to relevant regulatory and safety frameworks.

IEC 60601 – Electrical Safety & Essential Performance

VA/PT results demonstrate that cyber threats do not create unsafe electrical or functional conditions.

IEC 81001-5-1 – Cybersecurity Risk Management

Test findings support structured cyber risk identification, evaluation, and control.

IEC 62304 – Medical Device Software Lifecycle

VA/PT validates secure implementation and maintenance of software components.

ISO 14971 – Medical Device Risk Management

Cybersecurity vulnerabilities are linked to safety hazards and risk controls.

This multi-standard alignment strengthens regulatory confidence.

Common Vulnerabilities Found in Medical Electrical Devices

Cyberintelsys assessments often identify:

• Weak or hard-coded credentials

• Insecure network services or ports

• Insufficient segmentation between safety-critical and non-critical functions

• Outdated third-party software components

• Inadequate protection of service interfaces

Addressing these issues early reduces compliance risk.

Certification-Ready Reporting for Sweden and EU Markets

Cyberintelsys delivers clear, audit-ready VA/PT reports that include:

• Vulnerability descriptions and risk ratings

• Safety impact analysis

• Recommended remediation actions

• Evidence supporting IEC and EU MDR compliance

These reports are designed to meet the expectations of certification bodies and regulators.

Benefits of VA/PT for Medical Device Manufacturers in Sweden

Implementing IEC 60601-aligned VA/PT provides:

• Improved patient and user safety

• Reduced certification delays

• Stronger regulatory documentation

• Greater confidence in connected device security

• Faster market access in Sweden and the EU

Conclusion

IEC 60601 Vulnerability Assessment and Penetration Testing is a vital component of modern medical device safety and compliance. As medical electrical devices become more connected, cybersecurity testing ensures that digital risks do not undermine electrical safety or essential performance.

Cyberintelsys delivers expert VA/PT services in Sweden that integrate IEC 60601 with IEC 81001-5-1, IEC 62304, and ISO 14971, providing manufacturers with actionable insights and certification-ready evidence. By adopting a structured, standards-aligned VA/PT approach, manufacturers can confidently deliver safe, secure, and compliant medical electrical devices to the market.