claude-skills

risk-management-specialist

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.

quality-manager-qmr

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.

quality-documentation-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.

qms-audit-expert

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.

mdr-745-specialist

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.

isms-audit-expert

Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support. Use when the user mentions ISO 27001, ISMS audit, Annex A controls, Statement of Applicability (SOA), gap analysis, nonconformity management, internal audit, surveillance audit, or security certification preparation. Helps review control implementation evidence, document audit findings, classify nonconformities, generate risk-based audit plans, map controls to Annex A requirements, prepare Stage 1 and Stage 2 audit documentation, and support corrective action workflows.

information-security-manager-iso27001

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.

gdpr-dsgvo-expert

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.

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. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

capa-officer

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.

ux-researcher-designer

UX research and design toolkit for Senior UX Designer/Researcher including data-driven persona generation, journey mapping, usability testing frameworks, and research synthesis. Use for user research, persona creation, journey mapping, and design validation.

ui-design-system

UI design system toolkit for Senior UI Designer including design token generation, component documentation, responsive design calculations, and developer handoff tools. Use for creating design systems, maintaining visual consistency, and facilitating design-dev collaboration.

product-strategist

Strategic product leadership toolkit for Head of Product covering OKR cascade generation, quarterly planning, competitive landscape analysis, product vision documents, and team scaling proposals. Use when creating quarterly OKR documents, defining product goals or KPIs, building product roadmaps, running competitive analysis, drafting team structure or hiring plans, aligning product strategy across engineering and design, or generating cascaded goal hierarchies from company to team level.

product-manager-toolkit

Comprehensive toolkit for product managers including RICE prioritization, customer interview analysis, PRD templates, discovery frameworks, and go-to-market strategies. Use for feature prioritization, user research synthesis, requirement documentation, and product strategy development.

agile-product-owner

Agile product ownership for backlog management and sprint execution. Covers user story writing, acceptance criteria, sprint planning, and velocity tracking. Use for writing user stories, creating acceptance criteria, planning sprints, estimating story points, breaking down epics, or prioritizing backlog.

social-media-analyzer

Social media campaign analysis and performance tracking. Calculates engagement rates, ROI, and benchmarks across platforms. Use for analyzing social media performance, calculating engagement rate, measuring campaign ROI, comparing platform metrics, or benchmarking against industry standards.

marketing-strategy-pmm

Product marketing skill for positioning, GTM strategy, competitive intelligence, and product launches. Use when the user asks about product positioning, go-to-market planning, competitive analysis, target audience definition, ICP definition, market research, launch plans, or sales enablement. Covers April Dunford positioning, ICP definition, competitive battlecards, launch playbooks, and international market entry. Produces deliverables including positioning statements, battlecard documents, launch plans, and go-to-market strategies.

marketing-demand-acquisition

Creates demand generation campaigns, optimizes paid ad spend across LinkedIn, Google, and Meta, develops SEO strategies, and structures partnership programs for Series A+ startups scaling internationally. Use when planning marketing strategy, growth marketing, advertising campaigns, PPC optimization, lead generation, pipeline generation, or startup marketing budgets. Covers multi-channel acquisition (Google Ads, LinkedIn Ads, Meta Ads), CAC analysis, MQL/SQL workflows, attribution modeling, technical SEO, and co-marketing partnerships for hybrid PLG/Sales-Led motions in EU/US/Canada markets.

content-creator

Deprecated redirect skill that routes legacy 'content creator' requests to the correct specialist. Use when a user invokes 'content creator', asks to write a blog post, article, guide, or brand voice analysis (routes to content-production), or asks to plan content, build a topic cluster, or create a content calendar (routes to content-strategy). Does not handle requests directly — identifies user intent and redirects to content-production for writing/SEO/brand-voice tasks or content-strategy for planning tasks.

app-store-optimization

App Store Optimization (ASO) toolkit for researching keywords, analyzing competitor rankings, generating metadata suggestions, and improving app visibility on Apple App Store and Google Play Store. Use when the user asks about ASO, app store rankings, app metadata, app titles and descriptions, app store listings, app visibility, or mobile app marketing on iOS or Android. Supports keyword research and scoring, competitor keyword analysis, metadata optimization, A/B test planning, launch checklists, and tracking ranking changes.

tech-stack-evaluator

Technology stack evaluation and comparison with TCO analysis, security assessment, and ecosystem health scoring. Use when comparing frameworks, evaluating technology stacks, calculating total cost of ownership, assessing migration paths, or analyzing ecosystem viability.

tdd-guide

Test-driven development skill for writing unit tests, generating test fixtures and mocks, analyzing coverage gaps, and guiding red-green-refactor workflows across Jest, Pytest, JUnit, Vitest, and Mocha. Use when the user asks to write tests, improve test coverage, practice TDD, generate mocks or stubs, or mentions testing frameworks like Jest, pytest, or JUnit.

senior-security

Security engineering toolkit for threat modeling, vulnerability analysis, secure architecture, and penetration testing. Includes STRIDE analysis, OWASP guidance, cryptography patterns, and security scanning tools. Use when the user asks about security reviews, threat analysis, vulnerability assessments, secure coding practices, security audits, attack surface analysis, CVE remediation, or security best practices.

senior-secops

Senior SecOps engineer skill for application security, vulnerability management, compliance verification, and secure development practices. Runs SAST/DAST scans, generates CVE remediation plans, checks dependency vulnerabilities, creates security policies, enforces secure coding patterns, and automates compliance checks against SOC2, PCI-DSS, HIPAA, and GDPR. Use when conducting a security review or audit, responding to a CVE or security incident, hardening infrastructure, implementing authentication or secrets management, running penetration test prep, checking OWASP Top 10 exposure, or enforcing security controls in CI/CD pipelines.

senior-qa

Generates unit tests, integration tests, and E2E tests for React/Next.js applications. Scans components to create Jest + React Testing Library test stubs, analyzes Istanbul/LCOV coverage reports to surface gaps, scaffolds Playwright test files from Next.js routes, mocks API calls with MSW, creates test fixtures, and configures test runners. Use when the user asks to "generate tests", "write unit tests", "analyze test coverage", "scaffold E2E tests", "set up Playwright", "configure Jest", "implement testing patterns", or "improve test quality".

senior-prompt-engineer

This skill should be used when the user asks to "optimize prompts", "design prompt templates", "evaluate LLM outputs", "build agentic systems", "implement RAG", "create few-shot examples", "analyze token usage", or "design AI workflows". Use for prompt engineering patterns, LLM evaluation frameworks, agent architectures, and structured output design.

senior-ml-engineer

ML engineering skill for productionizing models, building MLOps pipelines, and integrating LLMs. Covers model deployment, feature stores, drift monitoring, RAG systems, and cost optimization. Use when the user asks about deploying ML models to production, setting up MLOps infrastructure (MLflow, Kubeflow, Kubernetes, Docker), monitoring model performance or drift, building RAG pipelines, or integrating LLM APIs with retry logic and cost controls. Focused on production and operational concerns rather than model research or initial training.

senior-fullstack

Fullstack development toolkit with project scaffolding for Next.js, FastAPI, MERN, and Django stacks, code quality analysis with security and complexity scoring, and stack selection guidance. Use when the user asks to "scaffold a new project", "create a Next.js app", "set up FastAPI with React", "analyze code quality", "audit my codebase", "what stack should I use", "generate project boilerplate", or mentions fullstack development, project setup, or tech stack comparison.

senior-frontend

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.

senior-devops

Comprehensive DevOps skill for CI/CD, infrastructure automation, containerization, and cloud platforms (AWS, GCP, Azure). Includes pipeline setup, infrastructure as code, deployment automation, and monitoring. Use when setting up pipelines, deploying applications, managing infrastructure, implementing monitoring, or optimizing deployment processes.

senior-data-scientist

World-class senior data scientist skill specialising in statistical modeling, experiment design, causal inference, and predictive analytics. Covers A/B testing (sample sizing, two-proportion z-tests, Bonferroni correction), difference-in-differences, feature engineering pipelines (Scikit-learn, XGBoost), cross-validated model evaluation (AUC-ROC, AUC-PR, SHAP), and MLflow experiment tracking — using Python (NumPy, Pandas, Scikit-learn), R, and SQL. Use when designing or analysing controlled experiments, building and evaluating classification or regression models, performing causal analysis on observational data, engineering features for structured tabular datasets, or translating statistical findings into data-driven business decisions.

senior-data-engineer

Data engineering skill for building scalable data pipelines, ETL/ELT systems, and data infrastructure. Expertise in Python, SQL, Spark, Airflow, dbt, Kafka, and modern data stack. Includes data modeling, pipeline orchestration, data quality, and DataOps. Use when designing data architectures, building data pipelines, optimizing data workflows, implementing data governance, or troubleshooting data issues.

senior-computer-vision

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.

senior-backend

Designs and implements backend systems including REST APIs, microservices, database architectures, authentication flows, and security hardening. Use when the user asks to "design REST APIs", "optimize database queries", "implement authentication", "build microservices", "review backend code", "set up GraphQL", "handle database migrations", or "load test APIs". Covers Node.js/Express/Fastify development, PostgreSQL optimization, API security, and backend architecture patterns.

senior-architect

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.

ms365-tenant-manager

Microsoft 365 tenant administration for Global Administrators. Automate M365 tenant setup, Office 365 admin tasks, Azure AD user management, Exchange Online configuration, Teams administration, and security policies. Generate PowerShell scripts for bulk operations, Conditional Access policies, license management, and compliance reporting. Use for M365 tenant manager, Office 365 admin, Azure AD users, Global Administrator, tenant configuration, or Microsoft 365 automation.

code-reviewer

Code review automation for TypeScript, JavaScript, Python, Go, Swift, Kotlin. Analyzes PRs for complexity and risk, checks code quality for SOLID violations and code smells, generates review reports. Use when reviewing pull requests, analyzing code quality, identifying issues, generating review checklists.

aws-solution-architect

Design AWS architectures for startups using serverless patterns and IaC templates. Use when asked to design serverless architecture, create CloudFormation templates, optimize AWS costs, set up CI/CD pipelines, or migrate to AWS. Covers Lambda, API Gateway, DynamoDB, ECS, Aurora, and cost optimization.

cto-advisor

Technical leadership guidance for engineering teams, architecture decisions, and technology strategy. Use when assessing technical debt, scaling engineering teams, evaluating technologies, making architecture decisions, establishing engineering metrics, or when user mentions CTO, tech debt, technical debt, team scaling, architecture decisions, technology evaluation, engineering metrics, DORA metrics, or technology strategy.

ceo-advisor

Executive leadership guidance for strategic decision-making, organizational development, and stakeholder management. Use when planning strategy, preparing board presentations, managing investors, developing organizational culture, making executive decisions, fundraising, or when user mentions CEO, strategic planning, board meetings, investor updates, organizational leadership, or executive strategy.