Overview
The rapid digitization of the Denmark healthcare sector driven by smart hospitals, telemedicine and connected medical equipment has increased cybersecurity risks. Modern medical devices operate on interconnected networks and software platforms making them vulnerable to cyber threats that can impact patient safety and disrupt clinical operations.
To address these risks, Vulnerability Assessment (VA) and Penetration Testing (PT) are essential components of medical device security. These assessments also form a key part of FDA 510(k) cybersecurity submission requirements for manufacturers planning to enter the U.S. market.
Cyberintelsys, a CREST-accredited cybersecurity company, provides specialized VA/PT services tailored to FDA 510(k) medical devices. Our team brings regulatory expertise, advanced testing methodologies and industry best practices to help manufacturers ensure device safety and compliance.
Why VA/PT Is Essential for FDA 510(k) Compliance
The FDA requires medical device manufacturers to demonstrate strong cybersecurity controls in their 510(k) submissions. Any unaddressed vulnerability can lead to data breaches, device malfunction or patient harm.
Key reasons VA/PT is crucial
• Early vulnerability discovery to detect design flaws, insecure configurations and software bugs
• Regulatory alignment with FDA cybersecurity documentation requirements
• Protection of patient safety by preventing cyberattacks that could disrupt device functionality
• Reputation and compliance protection reducing risk of recalls or approval delays
In the Denmark expanding medtech ecosystem healthcare organizations increasingly prefer working with CREST-accredited cybersecurity partners like Cyberintelsys for globally recognized and reliable testing services.
Cyberintelsys CREST-Accredited VA/PT Approach
Cyberintelsys follows international standards and FDA-recommended guidelines to deliver safe, accurate and compliant security testing for medical devices.
1. Scoping and Asset Identification
We begin by understanding your device architecture and ecosystem.
• Hardware, firmware and embedded components
• Communication interfaces such as Wi-Fi, Bluetooth, USB, TCP/IP and IoMT protocols
• Connected systems including mobile apps, cloud platforms and hospital networks
Deliverable: A clear test scope and asset inventory.
2. Vulnerability Assessment
• Automated scanning using tools like Nessus, OpenVAS and device-specific scanners
• Manual review of firmware, configuration settings and software components
• Configuration assessment of encryption, access controls and communication security
• Dependency analysis to identify risks in libraries, APIs and third-party components
Output: A comprehensive report with severity ratings, CVSS scores and remediation guidance.
3. Penetration Testing
• Network penetration testing of internal and external device interfaces
• Controlled exploitation to safely demonstrate real-world attack scenarios
• Wireless testing of Wi-Fi, Bluetooth, BLE, Zigbee and other IoMT communications
• Security testing of mobile and cloud interfaces including APIs, databases and companion apps
Deliverable: Proof-of-concept exploit results and impact assessment.
4. Risk Analysis and Prioritization
Each identified vulnerability is evaluated based on severity, exploitability, potential impact on patient safety and regulatory implications.
5. Reporting and FDA-Ready Documentation
• Detailed VA/PT report aligned with CREST and FDA 510(k) expectations
• Clear remediation instructions and security recommendations
• Gap analysis for future improvements
6. Retesting and Validation
After remediation Cyberintelsys performs retesting to confirm that vulnerabilities are fully resolved.
Methodology Overview
Cyberintelsys follows globally accepted frameworks and FDA cybersecurity guidelines.
Reconnaissance to identify device interfaces and software components
Threat modeling using frameworks such as STRIDE and MITRE ATT&CK
Controlled exploitation in a safe testing environment
Post-exploitation analysis to assess real-world impact
Reporting with detailed and actionable documentation
Benefits of Cyberintelsys Medical Device VA/PT Services
1. Regulatory Assurance
• FDA 510(k) aligned security documentation
• Faster readiness for premarket approval
2. Comprehensive Risk Mitigation
• Early detection of vulnerabilities
• Reduced operational and reputational risk
3. CREST-Certified Expertise
• Testing conducted by certified cybersecurity professionals
• Trusted and repeatable methodologies
4. Patient Safety and Confidence
• Strengthened protection against cyber threats
• Enhanced trust among hospitals and regulators
5. Continuous Security Improvement
• Support for secure development practices
• Periodic testing to address evolving threats
Industries and Devices We Support
Cyberintelsys provides VA/PT services for a wide range of FDA 510(k) medical devices.
• Diagnostic equipment including MRI, CT, X-ray and ultrasound
• Therapeutic devices such as infusion pumps, ventilators and laser systems
• Patient monitoring devices including wearables, IoMT equipment and telemetry systems
• Medical software including mobile health apps, cloud platforms and APIs
• Embedded and firmware-based medical devices
Why Cyberintelsys in Denmark
• CREST-accredited cybersecurity company providing globally recognized VA/PT services
• Technical expertise in embedded systems, firmware, cloud platforms, IoT and mobile applications
• Strong regulatory knowledge including FDA 510(k), IEC 81001-5-1, ISO 14971 and related standards
• Audit-ready reporting with clear evidence and remediation steps
• Deep understanding of the Denmark healthcare market and cyber risks
Conclusion
As the Denmark continues its digital transformation in healthcare securing medical devices is essential to ensuring patient safety and regulatory readiness. FDA 510(k) cybersecurity compliance is a key requirement for manufacturers seeking global market approval.
Cyberintelsys provides CREST-accredited VA/PT services that include
• Comprehensive vulnerability identification and exploitation analysis
• FDA-ready reporting and remediation guidance
• Enhanced device resilience and patient safety
• Improved readiness for successful FDA 510(k) submissions
Partner with Cyberintelsys to secure your medical devices and strengthen your position in the Denmark and global healthcare markets.
