Agent Skills Directory

Codebase Onboarding

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.

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.

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

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.

Database Designer - POWERFUL Tier Skill

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.

Memory health dashboard showing line counts, topic files, capacity, stale entries, and recommendations.

Dependency Auditor

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.

When the user wants to audit, redesign, or plan their website's structure, URL hierarchy, navigation design, or internal linking strategy. Use when the user mentions 'site architecture,' 'URL structure,' 'internal links,' 'site navigation,' 'breadcrumbs,' 'topic clusters,' 'hub pages,' 'orphan pages,' 'silo structure,' 'information architecture,' or 'website reorganization.' Also use when someone has SEO problems and the root cause is structural (not content or schema). NOT for content strategy decisions about what to write (use content-strategy) or for schema markup (use schema-markup).

When the user wants to implement, audit, or validate structured data (schema markup) on their website. Use when the user mentions 'structured data,' 'schema.org,' 'JSON-LD,' 'rich results,' 'rich snippets,' 'schema markup,' 'FAQ schema,' 'Product schema,' 'HowTo schema,' or 'structured data errors in Search Console.' Also use when someone asks why their content isn't showing rich results or wants to improve AI search visibility. NOT for general SEO audits (use seo-audit) or technical SEO crawl issues (use site-architecture).