This skill provides comprehensive guidance for engineering teams developing software for regulated medical devices. It assists in classifying software safety levels (Class A, B, or C), performing hazard analysis, and building robust risk management files according to ISO 14971. By integrating FDA premarket cybersecurity guidance and IEC 62304 lifecycle processes, the skill helps developers structure design controls, maintain traceability matrices, and prepare documentation for 510(k), PMA, or De Novo submissions, ensuring both technical excellence and regulatory readiness.
주요 기능
01ISO 14971 risk management and hazard analysis structuring
0211 GitHub stars
03FDA regulatory submission preparation (510(k), PMA, De Novo)
04Cybersecurity guidance including SBOM and vulnerability disclosure
05Design control implementation with automated traceability matrix support
06IEC 62304 software safety classification and lifecycle management
사용 사례
01Preparing cybersecurity documentation and SBOM for FDA premarket review
02Classifying software safety levels to determine documentation and testing rigor
03Developing a risk management file and hazard analysis for a new medical device