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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, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').

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qms-audit-expert

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.

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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 when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.

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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. 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.

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quality-manager-qms-iso13485

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.

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ra-qm-skills

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').

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regulatory-affairs-head

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 regulato

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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.

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soc2-compliance

Use when the user asks to prepare for SOC 2 audits, map Trust Service Criteria, build control matrices, collect audit evidence, perform gap analysis, or assess SOC 2 Type I vs Type II readiness.

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clinical-research

Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the stud

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market-research

Use when doing upstream market-research methodology — sizing a market as TAM/SAM/SOM computed BOTH top-down and bottoms-up (never a single unsourced number), planning a survey sample size with finite-population correction and per-segment minimums, or scoring candidate market segments against Kotler's measurable/substantial/accessible/differentiable/actionable criteria. Outputs always show the method and the assumptions. For market-research analysts and product-marketing at the sizing/survey/segmentation moment. Distinct from marketing-skill (campaign analytics, attribution, demand-gen) — this is the evidence-building methodology, not live-cam

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product-research

Use when planning and synthesizing product/user research as a method-and-repository discipline — selecting the right method for the goal (generative interviews vs usability test vs concept test vs validation), computing method-based saturation/sample size with an explicit confidence level, or synthesizing coded observations into insights while flagging single-source anecdotes. Never fabricates user insight; an insight requires recurrence across independent participants. Distinct from product-team/ux-researcher-designer (persona/journey artifacts), product-discovery (discovery-sprint planning), and experiment-designer (live A/B) — this is the

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research-finance

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).

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research-ops-skills

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 sub

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deep-research

Run a disciplined, multi-source research investigation for a high-stakes question or decision — fan-out web search across many channels, parallel sub-agents, source triangulation (each claim backed by ≥3 independent sources), an adversarial review pass, and every source saved to its own file with verbatim quotes for reuse. Use when a low-quality answer is expensive: strategy work, comparing N products/methods/markets, validating a hypothesis with external data, or mapping how a field works. NOT for quick fact-checks (answer directly), structured 12-dimension competitor scoring (use competitive-teardown), or fast topic overviews where the deci

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deepread

Use when the user asks to deeply read a book, article, PDF, or document set; extract claims and evidence; build a knowledge map; or learn through Feynman explanation and recall. Covers quick, deep, map, Feynman, and whole-book reading modes.

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dossier

Decision-grade entity research skill — produces a hypothesis-tested dossier on a specific company, person, nonprofit, or government org, not a generic profile. Forcing intake makes the user state their hypothesis upfront (what they already believe and want to verify or disprove) so the dossier tests it rather than confirms it. Output is an editable Word document (.docx) with verdict on the hypothesis, identity facts, 12-month activity timeline, network and reputation signals, red flags, conversation hooks tied to specific findings, and source-provenance audit log. Uses WebSearch + WebFetch + free APIs (SEC EDGAR, GitHub, ProPublica) as workho

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grants

NIH grant research skill for clinical researchers. Grill-me intake (research idea + career stage + preliminary data + environment + submission posture + known institute targets) locks down the funding strategy before any search runs. Runs a 5-facet Consensus positioning analysis (with draft Significance/Innovation language), maps the research to the right NIH institutes and study sections via RePORTER, finds NOSIs and funded overlap, and produces an editable Word document (.docx) with budget/scope-aware mechanism recommendations, submission timelines, and a mandatory program officer recommendation. Use when the user asks about research fundin

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litreview

Academic literature orientation skill that searches papers via free keyless APIs (PubMed E-utilities + OpenAlex) by default — with the Consensus MCP as an optional enhancement lane when connected — builds a strategic search plan using PICO (default) or SPIDER / Decomposition / hybrid as fallbacks, and synthesizes findings into a formatted Word (.docx) research guide. Grill-me intake (research question specificity + framework hint + tentative depth) before the recon search; a second forcing checkpoint after Phase 2 confirms framework + sub-areas + depth before searches consume budget. Configurable depth (5/10/20 queries) controls coverage vs.

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notebooklm

Browser automation skill for controlling Google's NotebookLM. Use when the user wants anything done in NotebookLM (e.g., 'open NotebookLM', 'check my [name] notebook', 'ask my notebook about X', 'add [source] to NotebookLM', 'generate a Video Overview from my notebook', 'use NotebookLM Studio'). Handles reading and querying notebooks, adding sources (URLs, text, files, YouTube links, synthesized content), generating Studio outputs (Audio/Video Overviews, Mind Maps, Reports incl. Briefing Doc/Study Guide/FAQ, Flashcards, Quiz, slide decks, infographics — discover the exact set from the live Studio panel; the UI evolves fast), and creating new

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patent

Patent prior-art and landscape intelligence skill — not generic patent help. Commits to one of five sub-use-cases via forcing intake (novelty search / freedom-to-operate / competitive landscape / acquisition diligence / litigation prior-art) before any search runs. Searches Google Patents, Espacenet, USPTO, and optionally Lens.org for citation-graph signals. Output is an editable Word document (.docx) with verdict, ranked closest art (claim-text extracted), CPC-class-aware landscape, family-resolved hits, geographic coverage, FTO flags where applicable, strategy recommendations, and full audit log. Use when the user asks for patent searching

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pulse

Multi-source recency research skill that takes the pulse of any topic across Reddit, Hacker News, the open web, and optionally X/Twitter within a configurable recent window (default 30 days). Forcing intake clarifies topic specificity, angle (trend/sentiment/problems/opportunities/comparison), time window, and platform scope before searching. Returns a synthesized briefing with citations, engagement metrics, and cross-platform pattern analysis. Use when the user requests multi-source recency intelligence on a topic (e.g., 'pulse on [topic]', 'what's happening with [topic]', 'what are people saying about [topic]', 'current conversation about [

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research

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, deepread for evidence-first reading of supplied documents) 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

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syllabus

Generates a curated supplementary reading list from any course syllabus using Consensus academic search. Grill-me intake (syllabus input format + course audience + year range) plus a grouping forcing-options checkpoint before any search runs — so the reading list matches the course's level and recency need. Parses the syllabus to extract topics and learning outcomes, searches Consensus for recent peer-reviewed papers per topic, and produces a professionally formatted .docx with clickable Consensus links, plain-language summaries calibrated to audience level, and Bloom-higher-order discussion questions tied to course learning goals. Use when t

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adaptyv

How to use the Adaptyv Bio Foundry API and Python SDK for protein experiment design, submission, and results retrieval. Use this skill whenever the user mentions Adaptyv, Foundry API, protein binding assays, protein screening experiments, BLI/SPR assays, thermostability assays, or wants to submit protein sequences for experimental characterization. Also trigger when code imports `adaptyv`, `adaptyv_sdk`, or `FoundryClient`, or references `foundry-api-public.adaptyvbio.com`.

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aeon

This skill should be used for time series machine learning tasks including classification, regression, clustering, forecasting, anomaly detection, segmentation, and similarity search. Use when working with temporal data, sequential patterns, or time-indexed observations requiring specialized algorithms beyond standard ML approaches. Particularly suited for univariate and multivariate time series analysis with scikit-learn compatible APIs.

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analytical-method-validation

Plan, execute, and document validation, verification, and transfer of analytical procedures under the governing framework - ICH Q2(R2) and Q14, USP <1220>/<1225>/<1226>, ICH M10 bioanalytical, CLSI EP, or ISO/IEC 17025. Use for HPLC, LC-MS/MS, GC, CE, ICP-MS, dissolution, qNMR, qPCR, NIR, and ligand binding or cell-based assays whenever the question is whether a procedure is fit for its intended purpose. Triggers include "method validation", "analytical method validation", "AMV", "validation protocol", "acceptance criteria", "linearity", "reportable range", "accuracy and precision", "repeatability", "intermediate precision", "recovery", "LOD"

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anndata

Data structure for annotated matrices in single-cell analysis. Use when working with .h5ad files or integrating with the scverse ecosystem. This is the data format skill—for analysis workflows use scanpy; for probabilistic models use scvi-tools; for population-scale queries use cellxgene-census.

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arbor

Autonomously improve a real artifact (code, training recipe, agent harness, data pipeline, prompt) against an objective and an evaluator, using Hypothesis Tree Refinement (HTR) from the Arbor paper. Use this whenever someone wants to iteratively optimize something over many experiments without overfitting — e.g. "get my model's eval score up", "improve this agent/harness", "tune this pipeline", "beat the baseline on this benchmark", "run a search over approaches and keep the best", "do an MLE-bench / Kaggle-style optimization", or any long-horizon "make this artifact better and don't just memorize the dev set" task. Trigger it even when the u

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