Overview
As medical devices in Ireland become more interconnected and reliant on software, cybersecurity has become a critical regulatory requirement for FDA 510(k) submissions. The U.S. FDA now mandates comprehensive cybersecurity documentation including risk assessments, SBOMs, testing evidence and secure design controls. For manufacturers seeking U.S. market entry, understanding and closing cybersecurity gaps early is essential to avoid delays, rejections or costly redesigns.
Cyberintelsys, a CREST-certified cybersecurity company, supports medical device companies across Ireland with specialized FDA 510(k) Cybersecurity Gap Analysis and Compliance Evaluation services. Our experts assess device architecture, software and security controls against the latest FDA guidance, ensuring manufacturers meet all requirements with confidence.
Why Cybersecurity Gap Analysis Matters for FDA 510(k) Approval
The FDA emphasizes that cybersecurity readiness directly impacts patient safety, device functionality and long-term product integrity. A gap in any security control can result in non-compliance, audit failures or increased regulatory scrutiny.
Key reasons gap analysis is essential:
Identifies weaknesses in device security early in the development cycle
Helps align design controls with FDA Pre-market Cybersecurity Guidance
Reduces risks of cyberattacks that could compromise patient health
Ensures manufacturers prepare accurate documentation for 510(k) submissions
Prevents unexpected delays or additional information requests from FDA reviewers
For Ireland based manufacturers, a structured cybersecurity evaluation helps streamline the path to U.S. market entry while enhancing device reliability and trust.
Cyberintelsys FDA 510(k) Cybersecurity Gap Analysis Approach
Cyberintelsys provides a comprehensive evaluation framework aligned with FDA guidance, industry best practices and global medical device standards. Our process ensures every cybersecurity control is assessed thoroughly and mapped to regulatory expectations.
1. Device Understanding & Scope Assessment
Our team begins by reviewing:
Device architecture, interfaces and intended use
Hardware, firmware, and software components
Connectivity features including Wi-Fi, Bluetooth, BLE, IoMT protocols
Backend systems such as mobile apps, APIs and cloud platforms
Deliverable: Scope document outlining assessment boundaries and device components.
2. Cybersecurity Control Evaluation
We evaluate each cybersecurity control outlined in FDA requirements:
Authentication & access control
Role-based permissions
Secure data transmission & encryption
Logging, audit trails, and security event handling
Secure storage and cryptographic controls
Update mechanisms and patching security
Time synchronization, monitoring and alerting
Each control is analyzed for adequacy, implementation maturity, and regulatory alignment.
3. Software Bill of Materials (SBOM) Review
We examine the device’s SBOM to ensure:
All third-party and open-source components are documented
Vulnerabilities (CVEs) are identified and assessed
Version management and dependency control practices meet FDA expectations
4. Threat Modeling & Risk Analysis
Using frameworks such as STRIDE and MITRE ATT&CK, we identify:
Potential attack vectors
Weak points in the device ecosystem
Misconfigurations or architectural risks
Threats that could impact patient safety
Deliverable: A risk matrix with impact severity and recommendations.
5. Vulnerability & Security Gap Identification
Our experts map all findings against FDA cybersecurity controls, including:
Secure product design
Secure development lifecycle (SDLC) practices
Risk management processes (ISO 14971 alignment)
Security testing evidence requirements
We identify gaps that must be addressed prior to the 510(k) submission.
6. Compliance Evaluation & Regulatory Mapping
Each cybersecurity element is aligned with:
FDA Premarket Cybersecurity Guidance
FDA Refuse-to-Accept (RTA) checklist
FDA 510(k) submission expectations
SBOM and patch management requirements
Deliverable: Detailed compliance scoring chart.
7. Remediation Roadmap & Documentation Support
Cyberintelsys provides:
A prioritized remediation plan for all identified gaps
Guidance on secure coding, hardening and risk mitigation
Support in preparing cybersecurity documentation for 510(k) submissions
Templates for security risk assessments, SBOM, traceability matrices and test evidence
8. Final Validation & Submission Readiness Review
Before submission, we conduct:
Reassessment of resolved gaps
Verification of evidence completeness
Validation of cybersecurity policies, reports, and technical files
Result: A complete cybersecurity package ready for submission to the FDA.
Benefits of Cyberintelsys Gap Analysis & Compliance Evaluation
Ensures full alignment with FDA cybersecurity expectations
Minimizes the risk of submission rejection or delays
Strengthens device protection against cyber threats
Helps manufacturers build secure-by-design medical devices
Provides clear remediation steps based on regulatory priority
Enhances market trust and product credibility
Devices & Industries We Support
Our cybersecurity assessment services cover:
Diagnostic devices (MRI, CT, X-ray, ultrasound)
Therapeutic devices (infusion pumps, ventilators, insulin pumps)
Homecare & wearable medical devices
IoMT and cloud-connected systems
Medical mobile apps and SaaS platforms
Firmware-driven and embedded medical devices
Why Choose Cyberintelsys in Ireland?
Expertise in FDA 510(k), IEC 60601, IEC 81001-5-1, ISO 14971 and ISO 27001
Deep understanding of medical device cybersecurity requirements
Strong experience with IoMT architecture and risk evaluation
Clear, audit-ready documentation tailored to FDA expectations
Local and global support for manufacturers entering the U.S. market
Conclusion
Cybersecurity has become a defining factor in achieving FDA 510(k) approval and Ireland’s growing medical device industry must stay ahead of evolving regulatory demands. Cyberintelsys helps manufacturers identify gaps early, resolve weaknesses efficiently and build secure, compliant devices ready for U.S. market entry.
Partner with Cyberintelsys to strengthen your cybersecurity posture, streamline your FDA submission and ensure your medical devices meet the highest standards of safety and regulatory compliance.
