FDA 510(k) Cybersecurity Gap Analysis & Compliance Evaluation | Medical Device Assessment Services in Thailand

As the U.S. healthcare system adopts more connected and software-driven medical devices, cybersecurity has become a mandatory regulatory requirement for FDA 510(k) submissions. Manufacturers in Thailand planning to access the U.S. market must demonstrate strong cybersecurity controls, documented risk mitigation, and validated testing results.

Cyberintelsys provides comprehensive FDA 510(k) Cybersecurity Gap Analysis and Compliance Evaluation services designed to help Thai medical device companies meet evolving cybersecurity expectations while accelerating regulatory approval.

Why Cybersecurity Gap Analysis Is Essential for FDA 510(k)?

The FDA requires medical device manufacturers to follow a secure-by-design approach and demonstrate that all cybersecurity risks have been analyzed, mitigated, and documented. A gap analysis identifies missing controls, weaknesses, and documentation deficiencies that can lead to submission delays or rejections.

Our cybersecurity gap evaluation helps manufacturers in Thailand:

  • Identify gaps against FDA cybersecurity controls

  • Strengthen device safety and resilience

  • Improve audit readiness and reduce regulatory risk

  • Ensure compliance with 2023–2025 FDA cybersecurity guidance

  • Accelerate approval for U.S. healthcare markets

Our FDA 510(k) Cybersecurity Gap Analysis & Compliance Services

Cyberintelsys delivers a structured, evidence-based approach to evaluating medical device security maturity.

1. System Architecture & Cybersecurity Design Review

We analyze your device’s system architecture, data flows, communication protocols, and security design.
Key components include:

  • Architecture threat exposure review

  • Protocol and data transmission evaluation

  • Firmware and software security design gaps

  • Access control and authentication mechanisms

2. Cybersecurity Documentation Gap Assessment

We evaluate your FDA-required documentation, including:

  • Secure design & development documentation

  • Cybersecurity risk management file

  • Threat modeling (STRIDE, DREAD, PASTA)

  • Validation & Verification (V&V) results

  • Postmarket security plan

3. Security Controls & Technical Safeguard Assessment

Our team reviews required cybersecurity controls such as:

  • Encryption (data at rest & in transit)

  • Identity and access control

  • Secure boot and firmware integrity

  • Logging, monitoring, and audit trails

  • Key and certificate management

4. Software Bill of Materials (SBOM) Compliance Review

We assess whether your SBOM meets FDA expectations.
Our SBOM review includes:

  • Component inventory completeness check

  • CVE/CWE vulnerability mapping

  • Software dependency risk scoring

  • FDA-formatted SBOM validation

5. Vulnerability Assessment & Penetration Testing (VA/PT) Gap Mapping

We evaluate your current test results and identify missing requirements.
This includes:

  • Firmware security testing gaps

  • Wireless & network protocol weaknesses

  • Mobile app and cloud dashboard testing gaps

  • API exploitation exposure

  • Device configuration vulnerabilities

6. Final Gap Report & Compliance Roadmap

Cyberintelsys provides a structured, FDA-ready report that includes:

  • All identified cybersecurity gaps

  • Severity scoring aligned with FDA guidelines

  • Technical remediation steps

  • Documentation improvement plan

  • Compliance checklist for FDA submission

Why Choose Cyberintelsys for FDA Cybersecurity Compliance in Thailand?

1. Deep Expertise in FDA Cybersecurity Requirements

Our security specialists understand FDA premarket cybersecurity guidelines and implement them effectively for Thailand-based manufacturers.

2. Complete 510(k) Cybersecurity Evaluation Lifecycle

We support every stage—from gap analysis to VAPT, SBOM, documentation, and security validation.

3. International Regulatory Alignment

We help align your device with:

  • FDA Premarket Cybersecurity Guidance

  • FDORA cybersecurity mandates

  • TPLC (Total Product Life Cycle) security framework

  • SBOM compliance requirements

4. Tailored for Thailand’s Medical Device Ecosystem

Cyberintelsys customizes solutions for the unique requirements of Thai manufacturers entering global markets.

Medical Devices We Support

Our services support various medical technologies, including:

  • IoMT devices

  • Wearable health devices

  • Diagnostic imaging systems

  • Remote patient monitoring solutions

  • Telehealth and telemedicine platforms

  • AI/ML-based medical devices

Begin Your FDA 510(k) Cybersecurity Gap Analysis Today

Whether your device is in early development or undergoing final submission preparations, Cyberintelsys provides the expertise needed to ensure full FDA cybersecurity compliance.

Reach out to our professionals

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