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.
8.1
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Business & Productivity
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Highly specialized skill providing comprehensive EU MDR 2017/745 compliance expertise for medical device regulation. The description clearly communicates the skill's regulatory consulting capabilities. The SKILL.md demonstrates deep domain knowledge with structured frameworks for classification, technical documentation, clinical evidence, UDI implementation, and post-market surveillance. The logical organization uses clear decision trees and workflows that guide users through complex regulatory processes. Structure is excellent with a well-organized overview and references to supporting files for templates, scripts, and detailed guidance. The skill addresses a highly specialized regulatory domain requiring extensive technical knowledge that would be extremely token-intensive for a CLI agent to replicate, making it cost-effective for organizations navigating MDR compliance. Minor improvement opportunities exist in making certain decision points even more explicit for autonomous agent execution.
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