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Found 1,381 Skills
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.
App Store Optimization toolkit for researching keywords, optimizing metadata, and tracking mobile app performance on Apple App Store and Google Play Store.
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
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.
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
Information Security Management System auditing for ISO 27001 compliance, security control assessment, and certification support
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.
This skill should be used when analyzing CSV datasets, handling missing values through intelligent imputation, and creating interactive dashboards to visualize data trends. Use this skill for tasks involving data quality assessment, automated missing value detection and filling, statistical analysis, and generating Plotly Dash dashboards for exploratory data analysis.
AI-agent readiness auditing for project documentation and workflows. Evaluates whether future Claude Code sessions can understand docs, execute workflows literally, and resume work effectively. Use when onboarding AI agents to a project or ensuring context continuity. Includes three specialized agents: context-auditor (AI-readability), workflow-validator (process executability), handoff-checker (session continuity). Use PROACTIVELY before handing off projects to other AI sessions or team members.