/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.

Design a structured case-control study framework with explicit source population logic, control selection rules, matching decisions, exposure measurement planning, and bias-control checkpoints.

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Convert a rambling description of a desired outcome into one polished, autonomous /goal prompt ready to paste into a fresh session. Use when the user says "/fable-goal", "turn this into a goal prompt", "write me a fable prompt", "write the prompt that builds X", or rambles about something they want made and asks for the prompt that makes it happen. The output is a single copy-paste prompt, never the build itself. Do NOT use when the user wants the thing built right now in this session — only when they want the PROMPT that will make it happen in a fresh session.

Designs complete integrated research plans for bulk transcriptomics, proteomics, metabolomics, and related omics from a user-provided biomedical direction. Always use this skill whenever a user wants to design, scope, or structure a bulk multi-omics or single-omics-plus-clinical study — including disease-focused, mechanism-focused, biomarker-focused, stratification-oriented, or translational projects. It should define the research question, choose the best-fit study pattern, recommend example datasets as reference candidates only, specify the core analysis modules and method choices, propose a validation ladder, and output four workload configurations (Lite / Standard / Advanced / Publication+). Never fabricate datasets, accession numbers, sample counts, metadata completeness, cohort availability, assay coverage, literature references, PMIDs, DOIs, or validation status. Always include the mandatory Dataset Disclaimer immediately before any workflow section that mentions datasets or public resources.

Turn a proven pattern or debugging solution into a standalone reusable skill with SKILL.md, reference docs, and examples. Use when the user runs /si:extract or asks to package a recurring solution from memory into a skill.

Use when planning product experiments, writing testable hypotheses, estimating sample size, prioritizing tests, or interpreting A/B outcomes with practical statistical rigor.

Generates complete bidirectional multi-phenotype Mendelian randomization research designs from a user-provided exposure family and outcome family. Always use this skill whenever a user wants to design, plan, or build a genome-wide causal-inference study based on publicly available GWAS summary statistics, especially when the article logic includes multiple exposures, multiple outcomes or subtypes, bidirectional MR, IV filtering, IVW as the main estimator, weighted median / MR-Egger / MR-PRESSO sensitivity analyses, leave-one-out testing, heterogeneity / pleiotropy checks, and multiple-testing control with FDR. Covers five study patterns (single-family bidirectional MR, multi-phenotype screening MR, subtype-resolved MR, phenome-style bidirectional causal map, mechanism-prioritized MR follow-up) and always outputs four workload configs (Lite / Standard / Advanced / Publication+) with recommended primary plan, step-by-step workflow, figure plan, validation strategy, minimal executable version...

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.

/cs:execute <decision> — Generate a 90-day execution plan with weekly milestones, DRIs, and check-in cadence from an approved decision. Use when a logged decision needs to become an operating plan — e.g. turning an approved market-entry call into weekly milestones with DRIs.

Evaluate and rank agent results by metric or LLM judge for an AgentHub session. Use when the user runs /hub:eval or asks to score, compare, or pick a winner among completed AgentHub agents.

Designs cell-based and animal-based validation plans that translate computational, omics, biomarker, genetic, or clinical findings into experimentally testable validation routes. Always use this skill whenever a user wants to move from an in silico, statistical, or clinical association finding toward wet-lab validation using cell systems, organoid-like systems, xenograft or genetically relevant animal models. It should define the exact claim to test, separate mechanism-testing from association-support and translational-support goals, choose the best-fit model family, specify perturbation strategy, readouts, controls, sequencing of experiments, and four workload configurations (Lite / Standard / Advanced / Publication+) with one recommended primary plan. Never fabricate model availability, reagent availability, species relevance, assay feasibility, phenotype penetrance, expected effect sizes, validation success, or literature references.

EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — prohibited (Art. 5), high-risk (Art. 6 + Annex III), limited-risk (Art. 50), or minimal-risk? (2) For high-risk systems, what's the Article 43 conformity assessment route (Module A internal control vs Module H full QMS + notified body) and what goes in the Annex IV technical documentation? (3) Per organizational role (provider / deployer / importer / distributor / authorized representative), what are the active obligations and deadlines? Use during AI system intake review, when planning conformity assessment, or when scoping deployer obligations. Cites Articles + Annexes for every output. NOT executive AI strategy (see chief-ai-officer-advisor). NOT a legal substitute.

Build immersive, cinematic 2.5D interactive websites using scroll storytelling, parallax depth, text animations, and premium scroll effects — no WebGL required. Use this skill for any web design task: landing pages, product sites, hero sections, scroll animations, parallax, sticky sections, section overlaps, floating products between sections, clip-path reveals, text that flies in from sides, words that light up on scroll, curtain drops, iris opens, card stacks, bleed typography, and any site that should feel cinematic or premium. Trigger on phrases like "make it feel alive", "Apple-style animation", "sections that overlap", "product rises between sections", "immersive", "scrollytelling", or any scroll-driven visual effect. Covers 45+ techniques across 8 categories. Always inspects, judges, and plans assets before coding. Use aggressively for ANY web design task.

Manage environment-variable hygiene and secrets safety across local development and production. Practical auditing, drift awareness, rotation readiness. Use when auditing .env files for committed secrets, planning a credential rotation, debugging missing-env-var production incidents, or hardening a new project against secrets leakage.

Designs primary aims, secondary aims, and testable hypotheses from broad biomedical research ideas. Use this skill when a user needs to convert a loose study idea into a tighter protocol-framing structure with clear aim hierarchy, hypothesis discipline, and separation between hypothesis-driven and exploratory components. Always keep aims answerable, non-overlapping, and aligned to the intended evidence type and study scope.

Index of the engineering-team skills bundle for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw, and 6 more tools. Architecture, frontend, backend, QA, DevOps, security, AI/ML, data engineering, Playwright, Stripe, AWS, MS365 (stdlib-only Python tools). Use when browsing or choosing among engineering-team role skills — load only the one specialist SKILL.md you need, never bulk-load the bundle.

Index of 37 advanced engineering agent skills for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. Use when browsing or choosing among the POWERFUL-tier engineering skills: agent design, RAG, MCP servers, CI/CD, database design, observability, security auditing, changelog/release automation, reliability (SLO/chaos/flags/operators), platform ops.

Generates complete FAERS pharmacovigilance study designs for multi-drug or class-level safety comparison inside one predefined SOC or AE family using active comparators, disproportionality analysis, subgroup characterization, and reviewer-facing evidence control.

Mentor for embedded and IoT hardware projects. Helps select MCUs, dev boards, and toolchains, decides where sensor readings end up (phone, PC, dashboard, or alert), and gives time/cost estimates and a phased build plan from breadboard MVP to production PCB. Use when the user mentions embedded, IoT, microcontroller, ESP32, STM32, Arduino, Raspberry Pi Pico, firmware, PCB, KiCad, EasyEDA, PlatformIO, MQTT, Home Assistant, ESPHome, Grafana, an IoT dashboard, seeing sensor data on a phone, or asks for hardware tool recommendations, project planning, or cost/time estimates for an electronics project.