ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.

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

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. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.

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.

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

Use when the user asks to design a RAG pipeline, choose a chunking strategy or embedding model, pick a vector database, or evaluate retrieval quality (precision@k, recall@k, NDCG). Examples: 'design a RAG system for our docs', 'what chunk size should I use for this corpus', 'evaluate my retriever against ground truth'. NOT for general LLM cost tuning (use llm-cost-optimizer) or agent loops over retrieval (use agenthub).

Use when planning or executing authorized red team engagements, attack path analysis, or offensive security simulations. Covers MITRE ATT&CK kill-chain planning, technique scoring, choke point identification, OPSEC risk assessment, and crown jewel targeting.

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.

Mid-conversation reflection skill that pauses execution and zooms out from detail-mode to honestly reassess direction, assumptions, and bias. Use when the user says 'reflect', 'take a step back', 'step back', 'zoom out', 'are we missing something', 'bigger picture', 'sanity check this', 'are we on track', 'are we overthinking this', 'forest for the trees', or any variation signaling intent to break out of detail-mode and reassess. Also trigger when the conversation has gone deep on implementation details without strategic check-in, or when the user shows signs of being stuck — that's often a signal the framing needs a reset, not more detail work. Intentionally low-intake: runs the 5-dimension analysis immediately when prior context is rich enough; asks one forcing clarifier only when invocation context is too thin to reassess from.

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.

Explicitly save important knowledge to auto-memory with timestamp and context. Use when a discovery is too important to rely on auto-capture.

Generate test report. Use when user says "test report", "results summary", "test status", "show results", "test dashboard", or "how did tests go".

Default entry point for any research request — a hybrid router that classifies the question deterministically and either delegates to a specialist research skill (pulse for trends/sentiment, grants for NIH funding, litreview for academic literature, syllabus for course reading, patent for prior-art + IP landscape, dossier for entity research) or runs its own plan-decompose-multi-source-search-synthesize-cite fallback workflow when no specialist matches. Always surfaces the routing decision so users can override. Use when the user makes any research request that doesn't obviously match a more-specific specialist skill (e.g., "research [topic]", "look into [topic]", "what do we know about [topic]", "investigate [topic]", "find me information on [topic]", "do some research on [topic]", "I need to understand [topic]"). Output is a markdown briefing (default) or .docx document (on request) with full citations and an audit log.

Use when managing the money for an internal R&D program or portfolio — building a multi-period program budget with the F&A (indirect) split, tracking burn rate and runway against value-inflection milestones, or routing R&D cost items to a capitalize-vs-expense determination. Every budget output surfaces its assumptions block; capitalize-vs-expense is decision-support only and routes to a named finance owner — it never books an entry or decides accounting treatment. Distinct from finance/financial-analysis (corporate DCF, close, valuation) and research/grants (funding discovery — this manages money already won).

Use when planning, funding, scoping, or synthesizing enterprise research across workstreams — clinical study design, R&D program finance, market sizing/surveys, or product/user research. Triggers on "design this clinical study", "what sample size", "R&D budget", "burn rate", "capitalize or expense", "TAM SAM SOM", "market sizing", "survey design", "segment the market", "plan user interviews", "usability test", "synthesize research insights". Forks context to route to one of four Research-Operations sub-skills (clinical-research, research-finance, market-research, product-research) and returns a digest. Distinct from ra-qm-team (regulatory submission), finance (corporate close/valuation), research/grants (funding discovery), product-team (persona/journey/live experiments), and marketing-skill (campaign analytics).

Structured research summarization agent skill for non-dev users. Handles academic papers, web articles, reports, and documentation. Extracts key findings, generates comparative analyses, and produces properly formatted citations. Use when: user wants to summarize a research paper, compare multiple sources, extract citations from documents, or create structured research briefs. Plugin for Claude Code, Codex, Gemini CLI, and OpenClaw.

Resume a paused experiment. Checkout the experiment branch, read results history, continue iterating. Use when the user runs /ar:resume or asks to pick up a previously started autoresearch experiment.

Analyzes sales pipeline health, revenue forecasting accuracy, and go-to-market efficiency metrics for SaaS revenue optimization. Use when analyzing sales pipeline coverage, forecasting revenue, evaluating go-to-market performance, reviewing sales metrics, assessing pipeline analysis, tracking forecast accuracy with MAPE, calculating GTM efficiency, or measuring sales efficiency and unit economics for SaaS teams.

Analyze auto-memory for promotion candidates, stale entries, consolidation opportunities, and health metrics. Use when the user runs /si:review or asks what has been learned and what should be promoted or pruned.

Use when an RFP, RFI, RFQ, security questionnaire, vendor questionnaire, or proposal request arrives and the team needs a structured response — parsing multi-section buyer-dictated requirements (MANDATORY vs WEIGHTED vs NICE-TO-HAVE), building a Shipley-method proof-point matrix mapping each requirement to a verifiable proof point, articulating 3-5 win-themes that ladder up across requirements, and producing a Shipley-derived winrate estimate that informs a bid / no-bid / partner-bid recommendation. For Bid Managers, Proposal Leads, Directors of Sales, and Sales Engineers at the response-strategy moment. Surfaces GAP requirements explicitly — never invents claims. NOT free-form proposal narrative authoring, NOT contract redline, NOT marketing collateral.

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.

Use when preparing roadmap narratives, release notes, changelogs, or stakeholder updates tailored for executives, engineering teams, and customers.

Use when someone asks to roast an idea, pressure-test or stress-test an idea, validate a business idea, "convene the panel", get a brutal second opinion before building something, or says "/roast". Spins up a 5-angle panel (Critic, Champion, Analyst, Investigator, Customer) that attacks the idea from every angle, then a Judge returns one GO / RESHAPE / KILL verdict with the cheapest test to de-risk it.

Run a single experiment iteration. Edit the target file, evaluate, keep or discard. Use when the user runs /ar:run or asks for one manual autoresearch iteration.