GXP CLOUD FOR MEDICAL DEVICES

Production record management that scales from prototype runs to high-volume manufacturing while maintaining full lot traceability per 21 CFR Part 820.184.

Technical Features:

• Lot genealogy tracking - Component-to-finished-device traceability matrices
• Real-time production linking - Integration with manufacturing execution systems (MES)
• Quality event correlation - Automatic CAPA and deviation cross-referencing
• Batch record validation - Pre-built templates for common device manufacturing processes
• Serialization support - UDI and lot number management with FDA submission formatting

Navigate FDA's October 2023 cybersecurity guidance with comprehensive risk assessments and documentation packages. Our cybersecurity professionals prepare submission-ready materials that demonstrate your cloud infrastructure meets FDA expectations for devices with cybersecurity functionality.

Pre-Market Cybersecurity Submissions:

FDA now requires detailed cybersecurity documentation for devices with software functions or connectivity capabilities. Our team provides complete 510(k) cybersecurity packages that address all FDA requirements without the typical 6-12 month learning curve.

Cybersecurity Risk Assessment (Primary Requirement):

• Device-specific threat modeling - Tailored risk analysis following FDA's recommended NIST Cybersecurity Framework approach
• Attack surface analysis - Comprehensive mapping of potential entry points including cloud APIs, data interfaces, and network connections
• Threat actor profiling - Healthcare-specific threat landscape assessment with medical device attack vector analysis
• Impact severity scoring - Patient safety and data integrity risk quantification using FDA-recognized methodologies
• Residual risk documentation - Post-mitigation risk levels with clinical justification for acceptability

Software Bill of Materials (SBOM) - Critical FDA Requirement:

• Complete dependency mapping - Every third-party component, library, and cloud service documented with version tracking
• Vulnerability correlation - Automated CVE mapping against SBOM components with severity scoring
• License compliance verification - Open source and commercial software license documentation
• Supply chain risk assessment - Vendor security posture evaluation for all SBOM components
• Maintenance and update procedures - Documented processes for SBOM updates throughout device lifecycle

Vulnerability Management Plans:

• Coordinated disclosure procedures - Structured protocols for vulnerability reporting and researcher engagement
• Patch management workflows - Risk-based patching procedures with clinical impact assessments
• Emergency response protocols - Rapid response procedures for zero-day vulnerabilities affecting patient safety
• Third-party vulnerability monitoring - Continuous scanning of cloud infrastructure and dependencies
• FDA reporting procedures - Clear protocols for when vulnerabilities require FDA notification per guidance

Network Architecture Documentation:

• Data flow diagrams - Complete mapping of protected health information (PHI) and device data flows
• Security control mapping - NIST 800-53 control implementation documentation with FDA-specific customizations
• Network segmentation plans - Isolation strategies for critical device functions and data processing
• Encryption specifications - End-to-end encryption implementation details with key management procedures
• Access control matrices - Role-based access controls with principle of least privilege documentation

Post-Market Cybersecurity Surveillance:

• Continuous monitoring architecture - Real-time threat detection and anomaly identification systems
• Incident response procedures - FDA-compliant cybersecurity incident reporting and remediation workflows
• Vulnerability disclosure tracking - Ongoing assessment of newly discovered vulnerabilities with impact analysis
• Performance monitoring integration - Cybersecurity metrics incorporation into device performance monitoring
• Annual cybersecurity assessments - Structured review processes with FDA reporting requirementsNavigate FDA's cybersecurity requirements with confidence. Our team prepares risk assessments and cybersecurity documentation that pass FDA review. 

ISO 14971 risk management specifically tailored to cloud infrastructure's role in medical device systems. Pre-built risk files, hazard analyses, and mitigation strategies eliminate months of regulatory preparation time.

Risk Management Deliverables:

• Cloud-specific hazard analysis - Data integrity, availability, and confidentiality risks
• Residual risk evaluation - Post-mitigation risk acceptability assessments
• Risk management file templates - Pre-validated documentation structures
• Usability engineering integration - IEC 62366 cloud interface risk assessments
• Risk-benefit analysis support - Clinical evaluation integration for cloud benefits

Seamless integration with existing development and manufacturing workflows while maintaining 21 CFR Part 11 electronic signature compliance and data integrity requirements.

Storage Features:

• Object immutability controls - Legal hold and retention policy enforcement
• Metadata management - Custom attributes for device-specific categorization
• Cross-region replication - Geographic redundancy for business continuity
• Access control integration - Role-based permissions with device team structures
• API compatibility - Drop-in replacement for existing S3 workflows

 We stand behind our infrastructure during FDA inspections, notified body audits, and customer quality system assessments. Our comprehensive documentation packages speak for themselves.

Audit Support:

• Regulatory documentation packages - Complete technical files for infrastructure components
• Inspector training materials - Educational resources for regulatory auditors
• Quality agreement templates - Pre-validated supplier agreements for medical device manufacturers
• Audit response procedures - Structured protocols for regulatory inquiries
• Expert witness support - Technical testimony for complex regulatory proceedings