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Found 15 Skills
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
Track compliance requirements and audit readiness. Trigger with "compliance", "audit prep", "SOC 2", "ISO 27001", "GDPR", "regulatory requirement", or when the user needs help tracking, preparing for, or documenting compliance activities.
Analyze test coverage gaps. Use when user says "test coverage", "what's not tested", "coverage gaps", "missing tests", "coverage report", or "what needs testing".
Systematically identify what's missing in non-fiction writing—both blind spots (inherent limitations) and blank spots (gaps that could be addressed). Use before finalizing non-fiction or when feedback feels incomplete.
Advisory plan review - validates plan correctness and identifies gaps before implementation. Works on any task with research and plan sections.
Audit Claude Code configuration against latest features and best practices. Use when user says "evolve", "self-improve", "audit config", "what's new in claude code", "upgrade configuration", "check for improvements", "are we up to date".
Эксперт по compliance отчётам. Используй для SOX, GDPR, HIPAA, SOC 2 аудитов и документации соответствия.
Correlates performance targets with actual profiling results. Identifies bottlenecks and validates against non-functional requirements.
Benchmarking and competitive analysis techniques. Compares performance, processes, and practices against industry standards, competitors, and best-in-class organizations.
Use for PLANNING documentation with phased analysis (4 phases), gap identification, and structured knowledge modeling. Best for documentation audits, completeness analysis, and documentation strategy planning. NOT for writing actual docs (use tasks-documentation instead).
Use when updating specifications, comparing branches, or ensuring documentation reflects current implementation.
Audit an implementation against a plan (docs/codex-plans/*). Use when a user asks to check for gaps, logic errors, or missing tests relative to a plan or Work Items.