Overview
Medical device manufacturers targeting the United States market from the United Kingdom must meet stringent FDA cybersecurity expectations as part of the FDA 510(k) premarket submission process. With medical devices becoming increasingly connected, software-driven, and integrated with hospital IT systems, cybersecurity has become a critical factor in patient safety, regulatory approval, and market success.
Cyberintelsys, a CREST -accredited cybersecurity company, delivers specialized Vulnerability Assessment (VA) and Penetration Testing (PT) services to support UK-based medical device manufacturers in achieving FDA 510(k) cybersecurity compliance. Our services align regulatory requirements with real-world security testing to ensure devices are safe, resilient, and submission-ready.
Why FDA 510(k) Cybersecurity Assessment Is Critical for UK Manufacturers?
Key reasons VA/PT is essential:
Regulatory compliance: Demonstrate alignment with FDA 510(k) cybersecurity guidance for US market access.
Patient safety: Reduce the risk of cyber threats impacting device functionality or patient outcomes.
Risk reduction: Identify and remediate vulnerabilities early to avoid delays, recalls, or enforcement actions.
Global credibility: Strengthen trust with regulators, healthcare providers, and partners.
Partnering with a CREST -accredited provider such as Cyberintelsys ensures penetration testing is conducted using internationally recognized and regulator-trusted methodologies.
Cyberintelsys’ FDA 510(k) VA/PT Approach
1. Scoping & Asset Identification
Identify device hardware, firmware, and software components
Map network connectivity, interfaces, and protocols (Wi-Fi, Bluetooth, TCP/IP, IoMT)
Review associated mobile, desktop, web, and cloud applications
Deliverables: Comprehensive asset inventory and testing scope definition.
2. Vulnerability Assessment (VA)
Automated vulnerability scanning using industry-leading tools
Manual assessment of firmware, configurations, and application logic
Security review of authentication, encryption, and access controls
Dependency analysis of third-party libraries and embedded components
Output: Detailed VA report including severity ratings, CVSS scoring, and remediation recommendations.
3. Penetration Testing (PT)
Network penetration testing (internal and external exposure)
Controlled exploitation of device interfaces to demonstrate real-world impact
Wireless testing for Bluetooth, Wi-Fi, and IoT communications
Security testing of APIs, mobile apps, and cloud platforms
Deliverable: Proof-of-concept exploit documentation suitable for FDA 510(k) submissions.
4. Risk Analysis & Prioritisation
Findings are prioritised based on patient safety impact, exploitability, and regulatory relevance.
5. Reporting & Compliance Documentation
CREST -aligned VA/PT reports ready for FDA 510(k) submission
Clear remediation guidance mapped to regulatory expectations
Cybersecurity gap analysis to support long-term improvement
6. Retesting & Validation
Verification testing to confirm vulnerabilities have been remediated and compliance objectives met.
Methodology Overview
Our VA/PT methodology aligns with global cybersecurity and medical device standards:
Reconnaissance: Mapping device attack surfaces and interfaces
Threat modelling: Using frameworks such as MITRE ATT&CK for ICS
Exploitation: Safe and controlled attack simulation
Impact analysis: Evaluating effects on device safety and clinical use
Reporting: Actionable, audit-ready documentation
Benefits of Cyberintelsys FDA 510(k) Services for UK Companies
1. Regulatory Readiness
Support FDA 510(k) cybersecurity evidence requirements
Reduce approval timelines through structured, high-quality reporting
2. Comprehensive Risk Mitigation
Identify high-risk vulnerabilities before market entry
Minimise financial, operational, and reputational risks
3. CREST-Accredited Expertise
Testing performed by certified ethical hackers
Globally recognised and repeatable testing methodologies
4. Patient Safety & Market Trust
Strengthen device resilience against cyber threats
Build confidence with hospitals, clinicians, and regulators
5. Continuous Security Improvement
Support secure development lifecycle (SDLC) integration
Enable ongoing compliance and post-market cybersecurity readiness
Medical Devices and Technologies Supported
Cyberintelsys supports a broad range of FDA 510(k) medical devices, including:
Diagnostic systems: Imaging, laboratory, and diagnostic devices
Therapeutic devices: Infusion pumps, ventilators, insulin delivery systems
Patient monitoring solutions: Wearables, telemetry, remote monitoring
Medical software and SaaS platforms
Embedded and connected IoMT devices
Why Choose Cyberintelsys in the United Kingdom?
CREST-accredited cybersecurity company: Trusted by regulators and global manufacturers
Medical device security expertise: Firmware, embedded systems, cloud, mobile, and IoMT
Regulatory alignment: FDA 510(k), IEC 60601 Compliance Services, IEC 81001-5-1, ISO 14971, ISA/IEC, NIST
Actionable reporting: Clear, evidence-based, audit-ready documentation
UK-focused support: Understanding of UK manufacturers exporting to the US market
Conclusion
For UK medical device manufacturers, achieving FDA 510(k) cybersecurity compliance is essential for accessing the United States healthcare market.
Cyberintelsys provides CREST -accredited Vulnerability Assessment and Penetration Testing services that enable:
Robust identification and validation of cybersecurity risks
FDA 510(k)-aligned documentation and remediation guidance
Improved patient safety and device resilience
Compliance readiness for successful US market entry
Partner with Cyberintelsys to achieve FDA 510(k) cybersecurity compliance and confidently bring your medical devices from the United Kingdom to the US market.