Medical Device Security
FDA 524B-Ready Security Testing for AI-Enabled Medical Devices
Accelerate clearance with SPDF-aligned testing across devices, firmware, AI, and cloud. Expert hardware and GenAI red teaming to reduce recalls and KEV exposure.
Testing mapped to NIST AI RMF, OWASP LLM Top 10, and MITRE ATLAS
Common Premarket Security Challenges
Modern connected devices face complex validation requirements
FDA 524B Compliance Gaps
Evolving premarket cybersecurity requirements lead to clearance delays, rework cycles, and uncertainty around SPDF evidence depth.
KEVs in Device Networks
Known exploited vulnerabilities persist in 23% of medical devices on provider networks, creating patient safety and recall risk.
AI Attack Paths Unvalidated
GenAI components in clinical workflows introduce new risks from prompt injection, RAG leakage, and unsafe agent actions that generic tests miss.
How OrbitCurve Accelerates Clearance
Comprehensive security research aligned to regulatory frameworks
524B-Ready Deliverables
Findings mapped to NIST AI RMF, OWASP LLM Top 10, and MITRE ATLAS with executive summaries and technical remediation guides for SPDF submission.
Full-Stack IoT Testing
Manual hardware hacking across device, firmware, mobile apps, cloud APIs, and OTA mechanisms with optional fault-injection and side-channel analysis.
System-Level AI Red Teaming
Tests prompts, agents, tools, RAG pipelines, and identity to surface real PHI leakage and unsafe action paths, not just prompt responses.
Why This Matters Now
Regulatory and field data highlight the stakes
FDA 524B now requires cybersecurity info for all submissions (510(k), PMA, De Novo, HDE)
Medical device recalls in FY2024, leading all FDA categories
Of medical devices on provider networks have at least one CISA known exploited vulnerability
Common Questions
Addressing typical concerns from product security and regulatory teams
Will an external team have access to sensitive data or PHI?
All testing is performed only under written authorization with clear rules of engagement. Confidentiality and data handling protocols are established upfront to protect sensitive information and comply with HIPAA requirements.
Will security assessments delay our release timeline?
Flexible scoping options (baseline, deep dive, or retainer) allow you to balance thoroughness with schedule. Prioritized findings and a retest plan ensure you can address critical issues first and iterate efficiently.
Get SPDF-Ready with Expert Testing
Schedule a call to discuss your device architecture, submission timeline, and testing scope options.
Schedule a Call524B requirements are active. Recall volume is rising. Start validation early.