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Found 3 Skills
Generate clinical trial protocols for medical devices or drugs. This skill should be used when users say "Create a clinical trial protocol", "Generate protocol for [device/drug]", "Help me design a clinical study", "Research similar trials for [intervention]", or when developing FDA submission documentation for investigational products.
Reason about SaMD (Software as a Medical Device) regulatory compliance for FDA, EU MDR, and global submissions. Use when the user asks about IEC 62304 safety classification, ISO 14971 risk management, 21 CFR 820/QMSR quality system requirements, Design History File structure, 510(k)/De Novo/PMA pathway selection, SOUP/OTS assessment, verification and validation planning, cybersecurity for medical devices, PCCP for AI/ML devices, design reviews, traceability matrices, or post-market surveillance. Triggers include "SaMD", "medical device software", "IEC 62304", "ISO 14971", "ISO 13485", "21 CFR 820", "QMSR", "510(k)", "De Novo", "PMA", "design history file", "DHF", "software safety classification", "SOUP list", "risk management", "hazard analysis", "design review", "V&V protocol", "FDA submission", "EU MDR", "clinical evaluation", "PCCP", "predetermined change control", "GMLP", "cybersecurity premarket", "Part 11", "design controls", "design inputs", "design outputs", "traceability matrix", "post-market surveillance", "CAPA", "Class II device", "Class III device", "regulatory pathway", "predicate device", "substantial equivalence".
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.