Provider Type:
Service Firm
Service Categories:
Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage Support:
Ready for 510(k)/MDR Submission
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
Standards Frameworks:
ISO 13485, MDR, FDA, HIPAA, NIST, IEC 62443, UL 2900
Pen Testing Available:
Yes
Threat Modeling Available:
Yes
Vulnerability Monitoring Available:
Yes