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Found 3 Skills
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.
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.
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'.