INTRODUCTION
As Egypt accelerates its adoption of digitally connected healthcare systems—ranging from telemedicine platforms and cloud-linked diagnostic devices to AI-powered patient monitoring—medical device manufacturers face rising demands for securing patient data and ensuring device integrity. The U.S. FDA’s 510(k) cybersecurity requirements have advanced rapidly, and for any Egyptian manufacturer planning to enter the U.S. market, cybersecurity is no longer optional—it is a central compliance requirement.
Cyberintelsys, a leading medical device cybersecurity and regulatory consulting partner in Egypt, supports manufacturers, innovators, and healthcare technology companies in achieving FDA 510(k) cybersecurity compliance, mitigating cyber risks, and ensuring their devices are fully prepared for global commercialization.
Why Cybersecurity Matters in 510(k) Submissions Today
With updated FDA cybersecurity guidance, every device with connectivity—wired, wireless, Bluetooth, cloud-based, or network-integrated—must demonstrate:
Strong cybersecurity controls
Secure-by-design product architecture
A validated cybersecurity risk management framework
Ongoing post-market cybersecurity maintenance
Cyberattacks can manipulate device performance, compromise patient safety, or expose sensitive health information.
Because of these risks, the FDA requires manufacturers to implement detailed cybersecurity strategies throughout the Total Product Lifecycle (TPLC).
The Growing Importance of Cybersecurity for Egyptian Medical Device Manufacturers
Egypt’s med-tech ecosystem is advancing rapidly with innovative solutions such as:
IoT-enabled medical devices
AI-based diagnostic tools
Telemedicine and remote care systems
Mobile health apps
Cloud-based medical software (SaMD)
Wearable patient monitoring devices
However, increased digital connectivity introduces new vulnerabilities.
Cyberintelsys helps Egyptian device manufacturers strengthen their cybersecurity posture and align design practices with FDA cybersecurity expectations from early development stages.
Cyberintelsys – Egypt’s Trusted Partner for FDA 510(k) Cybersecurity Readiness
Cyberintelsys delivers end-to-end cybersecurity compliance solutions tailored specifically for medical device manufacturers seeking U.S. FDA approval.
Our expertise spans security testing, SDLC documentation, risk management, cloud security assessment, and 510(k) cybersecurity file preparation—ensuring a smooth regulatory submission.
Comprehensive FDA 510(k) Cybersecurity Services by Cyberintelsys
Below is a full list of our specialized cybersecurity services for 510(k) submissions.
1. Pre-Submission Cybersecurity Gap Analysis
Cyberintelsys performs a comprehensive assessment to identify gaps between your existing product design and FDA expectations.
Our gap analysis covers:
Authentication and access control
Encryption (data at rest & in transit)
Secure communication channels
Cloud and API security posture
Network architecture assessment
Software and firmware vulnerability scanning
Endpoint & embedded security
This ensures you fully understand what the FDA expects before preparing your submission.
2. Secure Product Architecture Review (SPA)
Cyberintelsys evaluates your hardware, firmware, and software architecture to confirm that cybersecurity controls are structured effectively.
We assess:
Architecture and data flow diagrams
Potential threat exposure points
Physical, logical, and network interfaces
Cloud and integration security
Internal and external communication pathways
Security control alignment with system design
This step supports your Secure Development Lifecycle (SDLC) documentation—an FDA requirement.
3. Threat Modeling (TARA) & Cyber Risk Management Documentation
FDA mandates manufacturers to incorporate standardized threat analysis methodologies such as:
TARA
STRIDE
CVSS
Attack surface mapping
Cyberintelsys prepares comprehensive, audit-ready threat modeling and cybersecurity risk documentation for your 510(k) file.
4. Software Bill of Materials (SBOM) Creation
SBOMs are mandatory for all connected medical devices.
Cyberintelsys creates a complete SBOM including:
Open-source software components
Third-party libraries
Firmware elements
Dependency versions
CVE vulnerability mapping
We also deliver SBOM vulnerability remediation to bring your device into compliance.
5. Penetration Testing & Vulnerability Assessment for Medical Devices
Cyberintelsys’ technical experts conduct FDA-aligned cybersecurity validation:
Medical device penetration testing
Cloud and server security testing
API and middleware security evaluation
Wireless/Bluetooth testing
Firmware & embedded system VAPT
Application (web/mobile) security testing
We produce FDA-ready pen test reports containing:
Testing methodology
Screenshots and evidence
Exploit demonstration (if required)
Remediation guidance
6. Cybersecurity Documentation, Controls & Labelling for FDA Submission
Cyberintelsys prepares all mandatory FDA cybersecurity documentation, including:
Cybersecurity control implementation
Threat and risk mitigation strategies
Patch/update and version management process
Secure configuration guidelines
Cybersecurity testing validation
Incident response protocol
Post-market cybersecurity plan
Documents are drafted in FDA-approved format, ensuring clarity and regulatory acceptance.
7. Post-Market Cybersecurity Management (PMCF)
Cyberintelsys develops a complete post-market cybersecurity plan covering:
Continuous monitoring
Patch deployment and versioning
Vulnerability communication workflow
Re-assessment of residual risks
Incident management & reporting
This ensures long-term security across the device’s lifecycle.
Why Egyptian Manufacturers Choose Cyberintelsys
Egyptian medical device innovators trust Cyberintelsys because of our:
Deep understanding of FDA cybersecurity rules
Expertise in connected medical systems
End-to-end cybersecurity + regulatory capability
Highly skilled engineers and compliance experts
Quick delivery timelines
Zero rejection of cybersecurity documentation
Clear visibility into risks and corrective actions
Cyberintelsys ensures every Egyptian company developing a medical device is ready for international market entry.
Industries & Device Types Supported by Cyberintelsys
We support cybersecurity compliance for:
Diagnostic imaging devices
Remote patient monitoring systems
Telemedicine platforms
Wearable healthcare technology
Hospital IoT systems
SaMD and AI/ML medical software
Laboratory instruments
Surgical connectivity devices
Bluetooth-enabled instruments
Home-care IoT devices
Whether your product is a Class I, Class II, or Class III device, Cyberintelsys ensures full alignment with FDA cybersecurity standards.
Cyberintelsys’ 10-Step FDA 510(k) Cybersecurity Readiness Framework
Product evaluation & scoping
Cybersecurity architecture review
FDA regulatory gap analysis
Threat modeling (TARA/STRIDE)
SBOM creation & vulnerability scanning
Penetration testing & VAPT
SDLC documentation
Compliance-driven cybersecurity labeling
Evidence compilation
Final submission-readiness review
This framework ensures cybersecurity is integrated at every stage of development and documentation.
Accelerate Your FDA 510(k) Approval With Cyberintelsys
Cyberintelsys helps Egyptian medical device manufacturers:
Minimize risk of FDA submission rejection
Accelerate regulatory clearance timelines
Improve product cybersecurity resilience
Increase competitiveness in global markets
Enhance trust with hospitals, distributors & partners
Align with global cybersecurity frameworks
Our experts guide you through every technical and regulatory requirement for FDA 510(k) clearance.
Ready to Take Your Medical Device to the U.S. Market?
Partner With Cyberintelsys Today.
Whether your product is a wearable device, diagnostic system, telemedicine platform, AI-driven medical software, or cloud-linked medical IoT solution—Cyberintelsys is your trusted partner for FDA 510(k) cybersecurity compliance in Egypt.
