The healthcare sector in the Norway is rapidly adopting connected medical devices, IoMT systems, and cloud-integrated clinical equipment. As these devices become more interconnected, the cybersecurity requirements under IEC 60601 have become essential for ensuring patient safety and operational reliability.
Cyberintelsys provides specialized Medical Device Security Testing, Vulnerability Assessment (VA), and Penetration Testing (PT) services to help manufacturers, hospitals, and healthcare solution providers achieve IEC 60601 compliance and protect medical electrical equipment from cyber risks.
This blog explains why IEC 60601 cybersecurity matters, what testing is required, and how Cyberintelsys supports end-to-end compliance in the Norway .
What Is IEC 60601 and Why Is Cybersecurity Included?
IEC 60601 is the global standard governing the safety and essential performance of medical electrical equipment. Traditionally focused on electrical and mechanical safety, newer versions include cybersecurity considerations such as:
Protection against unauthorized access
Secure configuration and update mechanisms
Software and firmware integrity
Risk assessment for cybersecurity vulnerabilities
Defense against cyber threats targeting patient-connected equipment
Because modern medical devices communicate with networks, mobile apps, and cloud platforms, cybersecurity has become a mandatory part of the compliance process.
Why Is IEC 60601 Cybersecurity Important in the Norway ?
Healthcare providers in the Norway face increasing cyber threats such as ransomware, device tampering, data theft, and unauthorized system access. With more hospitals adopting digital platforms and IoMT devices, a single vulnerability can cause:
Device malfunction or operational disruption
Compromised patient safety
Altered clinical data or inaccurate diagnostic readings
Regulatory penalties or product recalls
Loss of trust among patients and healthcare partners
IEC 60601 cybersecurity ensures medical electrical equipment remains safe, secure, and compliant throughout its lifecycle.
Medical Device Security Testing for IEC 60601 Compliance
Cyberintelsys offers comprehensive medical device security testing aligned with IEC 60601 requirements, including:
1. Vulnerability Assessment (VA)
A detailed evaluation of cyber risks across all device components, including:
Firmware and embedded systems
Wireless communication modules
Mobile applications
API endpoints and cloud services
Network interfaces
User authentication and access control
VA helps identify weaknesses before malicious actors exploit them.
2. Penetration Testing (PT)
Simulated cyberattacks to validate real-world exploitability. Testing covers:
Network-based attacks
Wireless protocol exploitation (BLE, Wi-Fi, NFC, RFID)
Firmware tampering
Web interface and API exploitation
Mobile app security weaknesses
Cloud-integrated device vulnerabilities
PT demonstrates how cyber threats could compromise device function or safety.
3. Software, Firmware & Embedded Security Testing
Medical devices often contain complex embedded systems. We assess:
Firmware integrity and secure boot
Memory protection
Secure coding practices
Unauthorized firmware modification risks
Hardcoded credentials and insecure configurations
4. Risk Assessment & Threat Modeling (IEC 60601 + ISO 14971)
Cyberintelsys aligns cybersecurity risk analysis with:
IEC 60601 safety requirements
ISO 14971 risk management
IEC 81001-5-1 cybersecurity guidance
This ensures every identified cybersecurity risk is tied to patient safety and essential device function.
5. Communication & Interface Testing
Many devices communicate with hospital networks and cloud platforms.
We test:
Wi-Fi/BLE security
HL7, DICOM, MQTT, and proprietary protocols
API authentication and authorization
Cloud integration security
Data encryption and transmission integrity
Which Medical Devices Benefit from IEC 60601 Cybersecurity Testing?
Cyberintelsys supports a wide range of devices, including:
Patient monitors
Infusion pumps
Ventilators and respiratory systems
Imaging equipment (CT, MRI, ultrasound)
Wearables and IoMT sensors
Surgical and therapeutic devices
Hospital IT-connected systems
Home healthcare and remote monitoring devices
Any device requiring electrical safety approval under IEC 60601 should also undergo cybersecurity assessment.
How Cyberintelsys Conducts IEC 60601 VA/PT in the Norway ?
Our assessment approach is aligned with international standards and regulatory expectations.
1. Requirement and Architecture Review
We study:
Device design
Software architecture
Communication modules
Data flow
Safety-critical functionality
2. Test Case Mapping to IEC 60601 Requirements
We ensure cybersecurity tests align with relevant clauses.
3. Full VA/PT Execution
Performed on:
Hardware
Firmware
Network interfaces
Cloud dashboards
Mobile/desktop apps
4. Risk Scoring
Every vulnerability is mapped to:
Likelihood
Impact
Patient safety risk
Compliance requirements
5. Remediation Guidance
We provide actionable steps to fix vulnerabilities, improve design, and ensure secure operation.
6. Regulatory-Ready Documentation
Reports meet the requirements for:
IEC 60601 compliance audits
IEC 81001-5-1 cybersecurity submissions
Internal quality reviews
Hospital procurement evaluations
Why Choose Cyberintelsys for IEC 60601 Security Testing in the Norway ?
Specialized in medical device cybersecurity
Expertise in IEC 60601, IEC 81001-5-1, ISO 14971, FDA 510(k) cybersecurity
Skilled in embedded testing, firmware analysis, and wireless security
Philippine-focused regulatory understanding
CREST-certified security professionals
Clear, detailed, and audit-ready reporting
Support from early design to post-market surveillance
Cyberintelsys ensures your medical device is safe, secure, and compliant with global standards.
Strengthen Medical Device Cybersecurity and Achieve IEC 60601 Compliance
With cyber threats increasing across the healthcare ecosystem in the Norway , IEC 60601-aligned security testing is now essential—not optional.
Cyberintelsys provides end-to-end support, covering VA, PT, firmware testing, cloud security, and full risk assessment for medical electrical equipment