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:

1. Reconnaissance: Mapping device attack surfaces and interfaces

2. Threat modelling: Using frameworks such as MITRE ATT&CK for ICS

3. Exploitation: Safe and controlled attack simulation

4. Impact analysis: Evaluating effects on device safety and clinical use

5. 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.