Your Connected Device is a Target. Secure Your Regulatory Clearance.
Cybersecurity is Now the Top Reason for Regulatory Rejection.
Regulators no longer accept generic IT security policies. They demand comprehensive, device-specific threat modeling and verifiable intrusion defenses.
Advanced Threat Modeling & Architecture
We systematically map data flows and system boundaries to identify vulnerabilities, engineering robust mitigations directly into your software architecture.
Regulatory-Grade Documentation (CBOMs)
We generate the exact exhaustive documentation regulators demand, including Cybersecurity Bill of Materials (CBOM), mitigation reports, and incident response plans.
Penetration Testing Orchestration
We coordinate precise vulnerability scanning and penetration testing, translating complex technical findings into clear evidence of regulatory compliance.
Passing the Toughest Digital Safety Audits.
IoMT Network Defense
Re-architected the threat model for a cloud-connected patient monitoring system, demonstrating resilient data encryption to secure MFDS clearance without delays.
Digital Medical Products Act Alignment
Rapidly upgraded an older SaMD's cybersecurity documentation to comply with Korea's aggressive new digital health mandates, preventing a halted clearance.
Don't Let a Vulnerability Halt Your Launch.
Flawed cybersecurity architectures cause month-long regulatory holds. Get it right the first time.
Request a Cybersecurity AuditFrequently Asked Questions
Common queries about medical device cybersecurity.