Medical Device Security Testing & VA/PT for FDA 510(k) Compliance | Cyber Risk Experts in Denmark

FDA 510(k) Compliance Services Denmark

 

Overview

Medical devices are evolving rapidly as they become more software-driven, connected and interoperable across hospital networks, cloud platforms and mobile applications. While these advancements improve patient care, they also increase cybersecurity risks. In the Denmark growing healthcare and medical manufacturing ecosystem, ensuring that devices are secure and FDA 510(k) compliant is now essential for global market entry.

Cybersecurity testing, Vulnerability Assessment (VA) and Penetration Testing (PT) are key components of risk management for medical devices. These processes help manufacturers detect vulnerabilities early, strengthen device resilience and demonstrate compliance with FDA 510(k) premarket cybersecurity expectations.

Cyberintelsys, a CREST-accredited cybersecurity company trusted by medical device manufacturers internationally, provides specialized security testing, VA/PT and regulatory-focused assessment services for FDA 510(k) submissions in Denmark. Our experts support developers, importers and OEMs with deep cyber risk insights, device-centric testing methodologies and actionable compliance documentation.

Why Security Testing & VA/PT Matter for FDA 510(k) Compliance

The FDA requires medical device manufacturers to address cybersecurity risks in their design, development and premarket submissions. Inadequate security controls can lead to unauthorized access, data breaches, device malfunction or even patient harm.

Key reasons medical device VA/PT is critical:

  • Detect vulnerabilities in software, firmware and connectivity points before attackers exploit them

  • Meet FDA guidance on cybersecurity documentation for 510(k) submissions

  • Validate risk mitigation measures required under FDA and ISO 14971 expectations

  • Strengthen patient safety by ensuring device availability, integrity and confidentiality

  • Demonstrate global readiness for markets like the US, EU and APAC

  • Avoid costly delays, rejections or redesigning due to cybersecurity gaps

For manufacturers in Denmark aiming to submit devices to the U.S. market, robust cybersecurity testing and documented risk assessments are essential components of the regulatory pathway.

Cyberintelsys VA/PT & Security Testing Approach for FDA 510(k)

Cyberintelsys follows internationally recognized frameworks aligned with FDA, ISO 14971 and global cybersecurity best practices. Our testing methodology ensures thorough coverage of device attack surfaces while maintaining patient safety and device integrity.

1. Device Profiling & Scoping

We begin by analyzing the full device ecosystem, including:

  • Hardware architecture, embedded components and firmware

  • Mobile apps, web portals, cloud platforms and APIs

  • Wireless communication (Wi-Fi, Bluetooth, BLE, Zigbee, LTE, etc.)

  • Network interfaces and IoMT connectivity

  • Third-party libraries, software dependencies and integrations

Outcome: A clear testing scope and asset inventory tailored for FDA cybersecurity expectations.

2. Vulnerability Assessment (VA)

Our team performs a mix of automated and manual analysis to detect weaknesses across all components.

  • Static and dynamic code-level review

  • Firmware and binary analysis

  • Misconfiguration checks and secure design validation

  • Cryptography reviews

  • API and cloud security assessments

  • Software dependency and supply-chain vulnerability analysis

Deliverable: A detailed VA report including descriptions, CVSS scoring, screenshots and remediation steps.

3. Penetration Testing (PT)

We simulate realistic cyberattack scenarios to demonstrate actual exploitability without causing device harm.

  • Network penetration testing (internal and external)

  • Embedded system exploitation

  • Wireless attack simulations

  • Cloud and API exploitation testing

  • Reverse engineering of device firmware

  • Application-level penetration testing (mobile, desktop, web)

Deliverable: Proof-of-concept exploit documentation and evidence showing real-world attack pathways.

4. Cyber Risk Analysis & FDA-Aligned Documentation

All findings are analyzed according to regulatory and clinical impact.

We provide:

  • Risk scoring based on likelihood and severity

  • Mapping to FDA requirements and cybersecurity documentation

  • Threat modeling aligned with STRIDE or MITRE ATT&CK

  • Recommendations aligned with secure design principles

  • Residual risk analysis and mitigation strategies

This documentation is formatted for direct inclusion in FDA submissions.

5. Remediation Support & Retesting

Once your team applies corrective actions, Cyberintelsys conducts retesting to verify closure of vulnerabilities and produce updated compliance evidence.

Benefits of Cyberintelsys Security Testing for Denmark Manufacturers

1. Regulatory Confidence

  • FDA-ready documentation

  • Faster approval timelines

  • Reduced risk of submission rejection

2. Defense Against Cyber Threats

  • Identify critical vulnerabilities early

  • Reduce risk of attacks on connected devices

  • Improve resilience of IoMT ecosystems

3. End-to-End Device Coverage

  • Embedded systems

  • Cloud platforms

  • Mobile apps

  • Hospital network integrations

4. Expert Cyber Risk Guidance

Our experts combine cybersecurity, medical device engineering and regulatory compliance ensuring balanced, practical and safe recommendations.

Device Categories We Support

Cyberintelsys works with a wide variety of medical devices, including:

  • Patient monitoring systems

  • Diagnostic imaging equipment (MRI, CT, X-ray)

  • Infusion pumps, ventilators and life-support devices

  • Wearables and IoMT devices

  • Mobile health applications

  • Laboratory analyzers

  • Class II medical software

  • Cloud-based medical device platforms

Why Choose Cyberintelsys in Denmark?

  • Expertise in FDA 510(k) cybersecurity requirements

  • Proven experience with global medical device companies

  • Comprehensive VA/PT tailored to device design and risk class

  • Strong understanding of embedded security and IoMT communications

  • Actionable, audit-ready reporting

  • Commitment to patient safety and regulatory excellence

Cyberintelsys empowers Denmark medical device innovators to build secure, compliant and globally competitive products.

Conclusion

As medical devices continue to evolve, cybersecurity is no longer optional it is a foundational requirement for FDA 510(k) approval and global market readiness. Cyberintelsys equips manufacturers in Denmark with world-class medical device security testing, vulnerability assessment and penetration testing services to ensure:

  • Strong cybersecurity controls

  • FDA-aligned documentation

  • Reduced cyber and regulatory risks

  • Faster market access

  • Improved patient safety

Partner with Cyberintelsys to secure your medical devices and meet the cybersecurity standards required for successful FDA 510(k) compliance.

Reach out to our professionals

[email protected]