Agent Skills Directory

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.

Release Manager

Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.

This skill should be used when the user asks to "design system architecture", "evaluate microservices vs monolith", "create architecture diagrams", "analyze dependencies", "choose a database", "plan for scalability", "make technical decisions", or "review system design". Use for architecture decision records (ADRs), tech stack evaluation, system design reviews, dependency analysis, and generating architecture diagrams in Mermaid, PlantUML, or ASCII format.

Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.

Computer vision engineering skill for object detection, image segmentation, and visual AI systems. Covers CNN and Vision Transformer architectures, YOLO/Faster R-CNN/DETR detection, Mask R-CNN/SAM segmentation, and production deployment with ONNX/TensorRT. Includes PyTorch, torchvision, Ultralytics, Detectron2, and MMDetection frameworks. Use when building detection pipelines, training custom models, optimizing inference, or deploying vision systems.

Codebase Onboarding

Adversarial thinking partner for founders and executives. Stress-tests plans, prepares for brutal board meetings, dissects decisions with no good options, and forces honest post-mortems. Use when you need someone to find the holes before the board does, make a decision you've been avoiding, or understand what actually went wrong.

Database Schema Designer

Frontend development skill for React, Next.js, TypeScript, and Tailwind CSS applications. Use when building React components, optimizing Next.js performance, analyzing bundle sizes, scaffolding frontend projects, implementing accessibility, or reviewing frontend code quality.

Docker and container development agent skill and plugin for Dockerfile optimization, docker-compose orchestration, multi-stage builds, and container security hardening. Use when: user wants to optimize a Dockerfile, create or improve docker-compose configurations, implement multi-stage builds, audit container security, reduce image size, or follow container best practices. Covers build performance, layer caching, secret management, and production-ready container patterns.

Security leadership for growth-stage companies. Risk quantification in dollars, compliance roadmap (SOC 2/ISO 27001/HIPAA/GDPR), security architecture strategy, incident response leadership, and board-level security reporting. Use when building security programs, justifying security budget, selecting compliance frameworks, managing incidents, assessing vendor risk, or when user mentions CISO, security strategy, compliance roadmap, zero trust, or board security reporting.