claude-skills

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.

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.

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".

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, 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 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 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).

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).

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 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.

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.

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.

Analyze sprint retrospectives for patterns and action item tracking. Usage: /retro analyze <retro_data.json>

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.

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.

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.

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.

RICE feature prioritization with scoring and capacity planning. Usage: /rice prioritize <features.csv> [options]