Overview

As medical devices in Belgium 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 Belgium 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 Belgium 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 Belgium?

• 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 Belgium 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.