The global medical device landscape is evolving rapidly with digital connectivity, cloud integration and advanced software-driven functionalities becoming foundational to product performance. These innovations have significantly improved patient outcomes, yet they have also introduced new cyber risks that can directly affect device safety and reliability. To ensure safe entry into the United States market, the FDA now requires strong cybersecurity evidence as part of every 510(k) submission. This includes risk assessments, software documentation, SBOM preparation, secure design practices and validated cybersecurity controls.
For manufacturers in the Netherlands, achieving cybersecurity compliance can be complex without a structured and technically sound approach. Cyberintelsys, a trusted and CREST certified cybersecurity firm, supports medical device developers, manufacturers and importers across the Netherlands with specialized FDA 510(k) Cybersecurity Assessment and Compliance Readiness services. Our team helps organizations prepare accurate documentation, identify vulnerabilities early and implement robust security safeguards that align with the latest FDA guidance. With deep expertise in medical device cybersecurity, Cyberintelsys ensures companies can confidently meet regulatory expectations while strengthening product resilience.
FDA’s evolving cybersecurity expectations for 510(k) submissions
Over the past few years, the FDA has increasingly emphasized cybersecurity as an essential component of medical device safety. Connected devices such as diagnostic tools, remote monitoring systems, implantable technologies, digital therapeutics and software as a medical device (SaMD) are all required to demonstrate cybersecurity readiness during the premarket submission process.
The FDA expects manufacturers to:
Identify device cybersecurity risks
Implement secure-by-design engineering controls
Present transparent documentation of cybersecurity processes
Provide a Software Bill of Materials (SBOM)
Demonstrate secure update and patch management methods
Validate security features through testing
Maintain vulnerability communication procedures
Non-compliance can delay market-entry, expose organizations to FDA submission rejections or create safety concerns that impact patient well-being. This makes structured cybersecurity assessment and documentation essential for regulatory success.
Cyberintelsys supporting cybersecurity compliance for manufacturers in the Netherlands
Cyberintelsys provides medical device companies with end-to-end cybersecurity assessment and readiness solutions that align with FDA 510(k) requirements. Our support covers devices in all development stages including concept, engineering, validation, premarket submission and post-market maintenance.
We collaborate with regulatory teams, engineering teams and quality specialists to ensure seamless compliance preparation. Because we are a CREST certified cybersecurity company, our security assessments follow globally recognized standards of technical accuracy, risk identification and vulnerability evaluation. This enables manufacturers in the Netherlands to build stronger, safer and more compliant devices for the United States market.
Our comprehensive FDA 510(k) cybersecurity assessment and readiness methodology
1. Device cybersecurity baseline assessment
We begin every engagement with a detailed study of the device’s architecture, software stack, communication pathways, intended use and operational context. This initial assessment covers:
Hardware architecture
Software components and firmware
Connectivity methods such as Wi-Fi, Bluetooth or cellular
Third-party integrations
Cloud platforms or mobile applications
Data storage and transmission methods
User access control mechanisms
This deep technical understanding establishes the foundation required to evaluate risks and prepare FDA-aligned cybersecurity documentation.
2. Threat modelling and risk evaluation
Threat modelling is one of the most critical components in FDA 510(k) cybersecurity assessment. Using established frameworks such as STRIDE, attack tree analysis and risk scoring, Cyberintelsys identifies all plausible threats that could impact the device’s safety, performance or data security.
We evaluate:
Potential attack scenarios
Exploitable vulnerabilities
Weak security controls
Data exposure risks
Unauthorized access possibilities
Network infiltration opportunities
The results form a structured risk assessment that the FDA expects inside the 510(k) submission. We also provide mitigation recommendations to help manufacturers reduce unacceptable risks before entering the premarket submission stage.
3. Security control validation
The FDA requires manufacturers to demonstrate that security controls are effective, relevant and resilient. Cyberintelsys performs a wide range of validation activities to confirm whether device protections work as intended.
Testing may include:
Vulnerability assessment
Penetration testing
Interface and API security evaluation
Secure boot verification
Authentication and authorization assessment
Encryption strength review
Cloud and mobile application penetration testing
Firmware integrity verification
Because our team is CREST certified, all tests are conducted with strict methodologies that ensure accuracy and regulatory reliability. The results form a crucial part of the 510(k) cybersecurity evidence package.
4. Software Bill of Materials (SBOM) preparation and analysis
The FDA now requires every medical device submission to provide a clear and complete SBOM that lists all software components including third-party libraries and open-source code.
Cyberintelsys supports organizations by:
Reviewing or generating a complete SBOM
Identifying vulnerabilities within included components
Mapping components to known CVEs
Providing remediation strategies for high-risk elements
Ensuring SBOM formatting aligns with FDA expectations
A well-prepared SBOM improves transparency, reduces cybersecurity risks and strengthens the overall submission.
5. Verification of secure development practices
The FDA evaluates whether the device was developed using secure engineering principles. Cyberintelsys reviews secure coding practices, SDLC processes and development workflows to ensure they reflect cybersecurity best standards.
We help organizations align with:
Secure coding policies
Change management procedures
Patch management strategies
Identity and access control practices
Logging and monitoring methods
Post-market cybersecurity management plans
These processes collectively demonstrate that the device is designed and maintained with an emphasis on safety and resilience.
6. Cybersecurity documentation for FDA 510(k) submission
FDA submissions require clear, structured and complete documentation. Cyberintelsys assists manufacturers in preparing all required sections including:
Cybersecurity risk assessment reports
Threat modelling diagrams
Security testing evidence
SBOM reports
System architecture documentation
Vulnerability management strategy
Update and patch management procedures
Cybersecurity labeling content
Secure design documentation
Our documentation helps reduce FDA inquiries and accelerates the submission timeline.
Why medical device companies in the Netherlands choose Cyberintelsys
Cyberintelsys has a strong reputation for delivering accurate, technically sound and regulatory-compliant cybersecurity services. Medical device companies rely on us because we offer:
CREST certified cybersecurity expertise
Deep experience in medical device testing
Strong understanding of FDA expectations
Support across all device types and risk classifications
Customized strategies for complex devices
Submission-ready documentation
Faster readiness for 510(k) approval
Improved product resilience and market reliability
Our approach combines technical assessment with regulatory alignment which makes us a trusted partner for manufacturers preparing U.S. market submissions.
Medical device categories we support
Cyberintelsys works extensively with a wide range of device types including:
Imaging and diagnostic equipment
Wearable monitoring devices
Connected therapy systems
Implantable medical devices
Software as a Medical Device (SaMD)
Mobile medical apps
Cloud-connected platforms
Remote patient monitoring devices
AI and machine learning medical software
Each category requires precise cybersecurity considerations which our experts are fully equipped to address.
Conclusion: Strengthen your FDA 510(k) cybersecurity readiness with Cyberintelsys
As the FDA continues to raise its cybersecurity expectations, manufacturers must be proactive in securing their products and preparing accurate documentation. Cyberintelsys helps medical device companies across the Netherlands understand these requirements, implement strong cybersecurity controls and achieve compliance with confidence.
Whether you are developing a new device or preparing your next 510(k) submission, our team provides complete support to enhance security, meet regulatory standards and minimize risks.
Contact us today to begin your FDA 510(k) cybersecurity assessment and compliance readiness process.
