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Found 4 Skills
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".
Navigate Taiwan healthcare regulations including NHI system, medical device classification, drug registration, telemedicine rules, and health data protection. Use this skill when the user is building a health tech product for Taiwan, needs to understand NHI, evaluate medical device regulatory pathways, or assess telemedicine compliance — even if they say 'sell a medical device in Taiwan', 'how does NHI work', 'telemedicine regulations', or 'health data privacy in Taiwan'.
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.
Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.