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Found 3 Skills
EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation.
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.