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, ISO 14971, IEC 62304, IEC 82304, FDA 21 CFR Part 820, FDA 21 CFR Part 11, HIPAA, NIST CSF, NIST 800-53, NIST 800-171, UL 2900, MDR, GDPR
Pen Testing Available:
Yes
Threat Modeling Available:
Yes
Sbom Management Available:
No
Vulnerability Monitoring Available:
Yes
Rta Rescue Available:
No