mdr-745-specialist
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...
浏览 nimeshgurung 维护的已发布 AI 技能,比较用途与说明,并通过来源仓库了解安装方式。
已收录技能
48收录技能的仓库 Stars 合计
0仓库 Forks
48平均每个技能的仓库 Stars
0同一仓库中的多个技能可能共享 Stars,合计包含重复仓库数据。
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...
Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous...
Use when executing implementation plans with independent tasks in the current session - dispatches fresh subagent for each task with code review between tasks, enabling fast iteration with quality gates
Use when completing tasks, implementing major features, or before merging to verify work meets requirements - dispatches superpowers:code-reviewer subagent to review implementation against plan or requirements...
Use when creating or editing skills, before deployment, to verify they work under pressure and resist rationalization - applies RED-GREEN-REFACTOR cycle to process documentation by running baseline without skil...
Use when you've developed a broadly useful skill and want to contribute it upstream via pull request - guides process of branching, committing, pushing, and creating PR to contribute skills back to upstream rep...
Use when receiving code review feedback, before implementing suggestions, especially if feedback seems unclear or technically questionable - requires technical rigor and verification, not performative agreement...
Use when starting feature work that needs isolation from current workspace or before executing implementation plans - creates isolated git worktrees with smart directory selection and safety verification
Use when implementation is complete, all tests pass, and you need to decide how to integrate the work - guides completion of development work by presenting structured options for merge, PR, or cleanup
Use when implementing any feature or bugfix, before writing implementation code - write the test first, watch it fail, write minimal code to pass; ensures tests actually verify behavior by requiring failure fir...
Use when writing or changing tests, adding mocks, or tempted to add test-only methods to production code - prevents testing mock behavior, production pollution with test-only methods, and mocking without unders...
Use when tests have race conditions, timing dependencies, or inconsistent pass/fail behavior - replaces arbitrary timeouts with condition polling to wait for actual state changes, eliminating flaky tests from t...
Senior ISMS Audit Expert for internal and external information security management system auditing. Provides ISO 27001 audit expertise, security audit program management, security control assessment, and compli...
Senior Information Security Manager specializing in ISO 27001 and ISO 27002 implementation for HealthTech and MedTech companies. Provides ISMS implementation, cybersecurity risk assessment, security controls ma...
Use when design is complete and you need detailed implementation tasks for engineers with zero codebase context - creates comprehensive implementation plans with exact file paths, complete code examples, and ve...
Senior Quality Documentation Manager for comprehensive documentation control and regulatory document review. Provides document management system design, change control, configuration management, and regulatory...
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 inf...
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic qu...
Senior QMS Audit Expert for internal and external quality management system auditing. Provides ISO 13485 audit expertise, audit program management, nonconformity identification, and corrective action verificati...
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and...
ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control,...
Comprehensive security engineering skill for application security, penetration testing, security architecture, and compliance auditing. Includes security assessment tools, threat modeling, crypto implementation...
Use when starting any conversation - establishes mandatory workflows for finding and using skills, including using Skill tool before announcing usage, following brainstorming before coding, and creating TodoWri...
Use when encountering any bug, test failure, or unexpected behavior, before proposing fixes - four-phase framework (root cause investigation, pattern analysis, hypothesis testing, implementation) that ensures u...
默认按已收录数据中的 GitHub 仓库 Stars 排序。Stars 属于来源仓库,同一仓库的多个技能可能共享相同数值;它反映仓库关注度,不代表单个技能的安装量或质量评分。