fda-501k-toolkit

Use when auditing a medical-device software codebase for FDA 510(k) submission readiness, checking regulatory documentation and engineering evidence against FDA software guidance, or finding gaps in design controls, IEC 62304, ISO 14971, cybersecurity (SBOM, §524B), QMSR, human factors, or labeling. Keywords - 510(k), SaMD, premarket submission, substantial equivalence, device software functions, gap analysis.