Core clinical engineering and protocols for ISO 13485 Quality Management.
Many software startups struggle to reconcile fast two-week agile sprints with the rigorous documentation demands of ISO 13485 and FDA 21 CFR 820. MedicalSoftwareAI embeds design controls directly into Git workflows: user stories automatically link to regulatory requirements, pull requests generate design review records, and automated test runs produce signed verification evidence.
Under IEC 62304, all open-source libraries (PyTorch, NumPy, OpenCV) are classified as Software of Unknown Provenance (SOUP). We detail automated scanning frameworks that catalog all SOUP components, assess published vulnerabilities (CVEs), and verify functional reliability in production builds.