Medical Device Security Testing & VA/PT for FDA 510(k) Compliance | Cyber Risk Experts in Thailand

As cybersecurity becomes a core requirement in U.S. medical device regulations, manufacturers in Thailand must demonstrate robust security controls, validated testing results, and complete FDA-aligned documentation before entering the American healthcare market. Cyberintelsys provides comprehensive medical device security testing, Vulnerability Assessment & Penetration Testing (VA/PT), and FDA 510(k) cybersecurity compliance services tailored for Thai manufacturers preparing for global expansion.

Our enhanced compliance framework combines advanced technical testing, detailed cybersecurity documentation, and lifecycle risk management—ensuring your device meets the latest FDA 510(k) premarket cybersecurity expectations.

 

Why FDA 510(k) Cybersecurity Compliance Matters for Thai Manufacturers?

With the rise of advanced cyber threats targeting IoMT and connected medical devices, the FDA strengthened its cybersecurity requirements to ensure patient safety, data integrity, and device reliability.

Achieving FDA 510(k) cybersecurity compliance helps Thai manufacturers:

  • Prevent delays or rejections in FDA submissions

  • Demonstrate strong device safety and resilience

  • Protect patient data from cyberattacks

  • Improve product credibility in international markets

  • Accelerate entry into U.S. hospitals and healthcare systems

Cyberintelsys supports medical device companies in Thailand by ensuring their cybersecurity framework, testing results, and documentation align with FDA expectations.

Our FDA 510(k) Cybersecurity & VA/PT Services in Thailand

Cyberintelsys delivers end-to-end cybersecurity assessment, security testing, and documentation required for successful FDA 510(k) submissions.

1. FDA-Ready Cybersecurity Risk Assessment

Our risk assessment evaluates threats, vulnerabilities, communication pathways, and architecture-level risks across your device ecosystem.

We provide:

  • Attack surface discovery and mapping

  • STRIDE, DREAD, and PASTA threat modeling

  • Vulnerability identification and ranking

  • Security control validation

  • Actionable mitigation strategies

2. FDA 510(k) Medical Device VA/PT (Vulnerability Assessment & Penetration Testing)

Our VA/PT services follow FDA premarket cybersecurity guidance and simulate real-world attacker techniques.

Testing includes:

  • Firmware and OS penetration testing

  • Wireless protocol exploitation (BLE, Wi-Fi, NFC)

  • API and cloud penetration testing

  • Mobile application (Android/iOS) VA/PT under OWASP MASVS

  • Device configuration and access control testing

  • Data integrity, session hijacking, and protocol tampering tests

Deliverables include:

  • FDA-formatted VA/PT reports

  • CVE/CWE-linked findings

  • Technical evidence and attack chains

  • Risk scoring aligned with FDA methodologies

  • Remediation roadmap

3. SBOM (Software Bill of Materials) Development & Review

Cyberintelsys prepares complete SBOM documentation, including:

  • Component-level inventory (open-source + third-party)

  • CVE/CWE mapping

  • Vulnerability impact analysis

  • FDA-ready SBOM formatting

4. FDA Cybersecurity Documentation for 510(k)

We provide all cybersecurity documentation required for your FDA submission.

Documentation includes:

  • Cybersecurity risk management file

  • TPLC cybersecurity plan

  • Verification & Validation results

  • Secure development lifecycle evidence

  • Authentication & access control testing reports

  • Patch and update management strategy

  • Postmarket security monitoring plan

5. Encryption, Authentication & Access Control Validation

We verify the strength of your security mechanisms, including:

  • Data encryption testing (in transit and at rest)

  • Secure communication protocol validation

  • Key and certificate management review

  • Authentication and role-based access testing

  • Audit logging and traceability assessment

6. FDA Postmarket Cybersecurity Readiness

Cyberintelsys ensures long-term compliance through:

  • Secure firmware/software update mechanisms

  • Coordinated Vulnerability Disclosure (CVD) policy

  • Continuous threat monitoring strategy

  • Patch deployment and governance framework

Why Choose Cyberintelsys as Your FDA Cybersecurity Partner in Thailand?

1. Regulatory-Focused Cyber Expertise

Our cybersecurity team specializes in medical device regulatory compliance, ensuring every test and document aligns with U.S. FDA expectations.

2. End-to-End FDA 510(k) Cybersecurity Support

We provide a complete compliance package—from VA/PT and SBOM to documentation and lifecycle planning.

3. Based on 2023–2025 FDA Cybersecurity Requirements

Our services meet all modern FDA cybersecurity frameworks, including:

  • FDA Premarket Cybersecurity Guidance

  • FDORA cybersecurity requirements

  • Total Product Life Cycle (TPLC)

  • SBOM documentation mandates

4. Built for Thailand’s Medical Device Industry

Cyberintelsys customizes services to meet the needs of Thai device manufacturers targeting global markets.

Medical Devices We Support

We work with a wide range of healthcare and IoMT technologies, including:

  • Wearables & wireless health devices

  • Diagnostic equipment

  • Remote monitoring systems

  • AI/ML-driven medical devices

  • Infusion pumps and clinical machinery

  • Telemedicine devices

  • Cloud-connected healthcare platforms

Get FDA 510(k) Cybersecurity Testing & Compliance Support in Thailand

If you’re preparing to submit your medical device to the U.S. FDA, Cyberintelsys provides complete cybersecurity testing and documentation support to ensure full FDA 510(k) compliance.

Reach out to our professionals

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