IND · 02
Medical Devices
Submission-ready SBOMs, vulnerability posture, and lifecycle evidence for FDA premarket cybersecurity — governed by Siemens and Black Duck.
Regulatory frame
- FDA 524B
- MDR / IVDR
- IEC 81001-5-1
IND · 02
Submission-ready SBOMs, vulnerability posture, and lifecycle evidence for FDA premarket cybersecurity — governed by Siemens and Black Duck.