Medical Device Cybersecurity
Medical Device Threat Modeling
We perform threat modeling for connected medical devices following IEC 62443 and FDA premarket cybersecurity guidance. Risk profiles are mapped against device architecture and clinical workflows.
Legacy System Security Audit
We assess legacy medical software (C/C++, Delphi) for known CVEs, insecure protocols, and outdated cryptographic implementations. Findings are prioritized by clinical impact severity.
IEC 62443 Compliance
We guide manufacturers through IEC 62443 security levels for industrial automation and control systems used in medical environments. Gap analysis, zone/conduit modeling, and remediation roadmaps included.
FDA Premarket Cybersecurity
We prepare FDA 510(k) cybersecurity documentation including SBOM generation, vulnerability disclosure policies, and postmarket surveillance plans aligned with FDA guidance.
Secure Code Remediation
Hands-on C/C++ and Delphi code hardening for medical device firmware. We implement secure boot, encrypted communications, input validation, and memory safety improvements.
Postmarket Surveillance & SBOM
Ongoing vulnerability monitoring, SBOM maintenance, and coordinated disclosure processes. We ensure your devices remain compliant throughout their lifecycle as regulations evolve.