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research-ops-skills
This skill supports enterprise research across workstreams such as clinical study design, R&D finance, market sizing, and product/user research. It triggers on queries related to these areas, including study design, budgeting, and market analysis.
risk-management-specialist
Medical device risk management specialist implementing ISO 14971 throughout the product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
inbox-triage
Performs a full inbox triage using the knowledge base from the 'inbox-setup' skill. Designed for light intake, it typically skips questions and uses default preferences, asking at most two override questions in unusual situations.
pm-skills
6 project management agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. Includes Senior PM, scrum master, Jira expert (JQL), Confluence expert, Atlassian admin, and template creator, with MCP integration for live Jira/Confluence automation.
gdpr-dsgvo-expert
Automates GDPR and German DSGVO compliance by scanning codebases for privacy risks, generating DPIA documentation, and tracking data subject rights requests. It's used for compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS, covering audit planning, execution, nonconformity classification, and CAPA verification. This skill is useful for internal audit planning, execution, finding classification, external audit preparation, and audit program management.
research-finance
This skill manages finances for internal R&D programs or portfolios, covering multi-period budgeting with F&A splits, tracking burn rates against milestones, and routing R&D costs for capitalize-vs-expense decisions. Budget outputs include assumption blocks, and the capitalize-vs-expense feature provides decision support.
eu-ai-act-specialist
Operational compliance with the EU AI Act (Regulation (EU) 2024/1689) for compliance teams. This involves determining an AI system's risk tier (prohibited, high-risk, limited-risk, or minimal-risk) and, for high-risk systems, the Article 43 conformity assessment route.
claude-skills
337 Claude Code skills, agent skills, and plugins, featuring over 30 agents, 70 custom commands, and 330 skills. These are compatible with Claude Code, Codex, Gemini CLI, Cursor, and 8 other coding agents, supporting diverse functions from engineering and marketing to C-level advisory and daily productivity.
fda-consultant-specialist
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.
claude-skills
Explore 337 Claude Code and agent skills & plugins, including 30+ agents and 330+ skills, compatible with Claude Code, Codex, Gemini CLI, Cursor, and 8 other coding agents. These tools support diverse areas from engineering and marketing to C-level advisory and daily productivity.
claude-skills
This package offers 337 Claude Code skills, agent skills, and plugins, including over 30 agents, 70 custom commands, and 330 skills with customizable references and scripts. It supports Claude Code, Codex, Gemini CLI, Cursor, and 8 other coding agents, covering areas like engineering, marketing, product, compliance, C-level advisory, research, business operations, commercial & finance, and daily productivity.