Agent Skills Directory

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.

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.

Cross-functional what-if modeling for cascading multi-variable scenarios. Unlike single-assumption stress testing, this models compound adversity across all business functions simultaneously. Use when facing complex risk scenarios, strategic decisions with major downside, or when the user asks 'what if X AND Y both happen?'

When the user wants to design, launch, or optimize a referral or affiliate program. Use when they mention 'referral program,' 'affiliate program,' 'word of mouth,' 'refer a friend,' 'incentive program,' 'customer referrals,' 'brand ambassador,' 'partner program,' 'referral link,' or 'growth through referrals.' Covers program mechanics, incentive design, and optimization — not just the idea of referrals but the actual system.

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.

International market expansion strategy. Market selection, entry modes, localization, regulatory compliance, and go-to-market by region. Use when expanding to new countries, evaluating international markets, planning localization, or building regional teams.

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.

Systematic competitor tracking that feeds CMO positioning, CRO battlecards, and CPO roadmap decisions. Use when analyzing competitors, building sales battlecards, tracking market moves, positioning against alternatives, or when user mentions competitive intelligence, competitive analysis, competitor research, battlecards, win/loss, or market positioning.

SaaS financial health advisor. Use when a user shares revenue or customer numbers, or mentions ARR, MRR, churn, LTV, CAC, NRR, or asks how their SaaS business is doing.

Contract & Proposal Writer

/em -stress-test — Business Assumption Stress Testing

Design, optimize, and communicate SaaS pricing — tier structure, value metrics, pricing pages, and price increase strategy. Use when building a pricing model from scratch, redesigning existing pricing, planning a price increase, or improving a pricing page. Trigger keywords: pricing tiers, pricing page, price increase, packaging, value metric, per seat pricing, usage-based pricing, freemium, good-better-best, pricing strategy, monetization, pricing page conversion, Van Westendorp. NOT for broader product strategy — use product-strategist for that. NOT for customer success or renewals — use customer-success-manager for expansion revenue.