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fda-qsr-audit-prep

alirezarezvani/claude-skills

/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.

Skills

alirezarezvani/claude-skills

/cs:compliance-readiness <program> — Multi-framework compliance officer 6-question forcing interrogation of any compliance program. Use before starting a new framework, planning the annual audit calendar, or preparing for certification stage 1.

Skills

aipoch/medical-research-skills

Analyze data with `survival-curve-risk-table` using a reproducible workflow, explicit validation, and structured outputs for review-ready interpretation.

Skills

aipoch/medical-research-skills

Kaplan-Meier survival analysis tool for clinical and biological research. Generates publication-ready survival curves with statistical tests.

Skills

alirezarezvani/claude-skills

Compliance OS — meta-orchestrator that lets compliance teams CONFIGURE which frameworks apply, COMPUTE cross-framework control overlap, SIMULATE internal audits, and CONSOLIDATE evidence across multiple frameworks. Four decisions: (1) Given a company profile, which of the 12 supported frameworks apply (ISO 27001/13485/42001/14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR, NIST CSF 2.0, NIS2, HIPAA)? (2) Across selected frameworks, which controls overlap and how much evidence reuses? (3) For a given framework + scope, what does a realistic mock audit produce — drawing from the 205-scenario library? (4) Across selected frameworks, what's the unified evidence checklist with reuse map? Use when standing up a multi-framework program, planning the annual audit calendar, or preparing for certification stage 1. Does NOT replace per-framework skills (it orchestrates them).

Skills

alirezarezvani/claude-skills

/cs:aims-audit <scope> — ISO/IEC 42001 AIMS internal-audit 6-question forcing interrogation. Use before certification stage 1, before annual internal audit cycles, or when onboarding a new AI system into an existing AIMS.

Skills

alirezarezvani/claude-skills

/cs:ai-act-readiness <system> — EU AI Act 6-question forcing interrogation. Use during AI-system intake, before EU deployment, or during annual compliance refresh as Article 113 obligations phase in (2025-02-02 / 2025-08-02 / 2026-08-02 / 2027-08-02).

Skills

aipoch/medical-research-skills

Determines the appropriate Risk of Bias assessment scale for a medical study based on its design (RCT, Cohort, etc.), using PubMed metadata lookup or text analysis. Use when the user wants to know which quality assessment tool to use for a specific paper (given PMID or abstract).

Skills

alirezarezvani/claude-skills

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.

Skills

aipoch/medical-research-skills

Guided statistical analysis for test selection, assumption checks, power analysis, and APA-style reporting. Use when you need to choose an appropriate statistical test for your data and produce publication-ready results (including effect sizes and diagnostics).

Skills

alirezarezvani/claude-skills

Use when designing or revisiting product pricing — selecting a pricing model (subscription seat-based, usage-based, value-based, freemium, or hybrid), running Van Westendorp Price Sensitivity Meter analysis on WTP survey data, or designing Good/Better/Best packaging tiers. Recommends a model and a price range with trade-offs, never a single number. For Commercial leads, Product Marketing, and CMOs at the pricing-design moment — not deal-by-deal discounting, not brand positioning.

Skills

aipoch/medical-research-skills

Recommends appropriate statistical methods (T-test vs ANOVA, etc.) based.

Skills

aipoch/medical-research-skills

Map spatial transcriptomics data from 10x Genomics Visium/Xenium onto.

Skills

alirezarezvani/claude-skills

Use when a startup is approached by a prospective partner and someone has to decide should we sign this partner, at what partner tier (referral / reseller / OEM / SI-consulting / strategic alliance), with what joint GTM commitment, and at what revshare. Classifies partner tier from independent-demand evidence vs. preferential-terms hunting, designs a 90-day joint GTM plan, models revshare against direct-sale margin, and surfaces kill criteria for unwinding under-performing partnerships. For Head of Partnerships, Head of BD, and Founder-CEOs doing reseller agreement, OEM deal, or strategic alliance review — not technical sale enablement, not channel cost economics, not M&A.

Skills

aipoch/medical-research-skills

Analyze data with `smiles-de-salter` using a reproducible workflow, explicit validation, and structured outputs for review-ready interpretation.

Skills

aipoch/medical-research-skills

Programmatically query public single-cell study metadata from the Broad Institute Single Cell Portal REST API when you need to search and filter datasets by organism, tissue, disease, or cell type without an API key.

Skills

alirezarezvani/claude-skills

Use when reviewing a specific inbound deal before close — when sales has asked for a discount that exceeds AE authority, when the customer has redlined the MSA, when per-deal economics (margin after discount, multi-year payment shape, indemnity exposure) need to be quantified, or when discount approval needs to be routed to a named human approver (Sales Director, VP Sales, CFO, CRO, General Counsel). Covers deal review, discount approval routing, per-deal margin scoring, deal exception handling, MSA redline triage, contract landmine detection (uncapped indemnity, MFN, perpetual license-back, missing DPA), and named-approver chain assembly. NEVER auto-approves — every output is a numeric scorecard plus a routing recommendation to a named human.

Skills

alirezarezvani/claude-skills

Use when reviewing, approving, or designing commercial motion — pricing models, deal review, discount approval, partnership economics, channel mix, commercial policy, RFP/RFI response, bookings forecast. Triggers on "review this deal", "should we discount", "pricing model", "partner economics", "RFP response", "bookings forecast", "channel mix". Forks context to route to one of seven Commercial sub-skills (pricing-strategist, deal-desk, partnerships-architect, channel-economics, commercial-policy, rfp-responder, commercial-forecaster) and returns a digest. Distinct from business-growth (sales execution) and c-level-advisor/cro-advisor (strategic CRO judgment).

Skills

aipoch/medical-research-skills

Model interpretability and explainability using SHAP (SHapley Additive exPlanations). Feature importance, dependence plots, interaction effects, and fairness analysis for any black-box model.

Skills

aipoch/medical-research-skills

A skill for performing sequence alignment using NCBI BLAST API. Supports nucleotide and protein sequence comparison against major biological databases.

Skills

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