Agent Skills Directory

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.

Send USDC to an Ethereum address or ENS name. Use when you or the user want to send money, pay someone, transfer USDC, tip, donate, or send funds to a wallet address or .eth name. Covers phrases like "send $5 to", "pay 0x...", or "transfer to vitalik.eth".

Reconcile accounts by comparing GL balances to subledgers, bank statements, or third-party data. Use when performing bank reconciliations, GL-to-subledger recs, intercompany reconciliations, or identifying and categorizing reconciling items.

Prepare journal entries with proper debits, credits, and supporting detail. Use when booking month-end accruals (AP, payroll, prepaid), recording depreciation or amortization, posting revenue recognition or deferred revenue adjustments, or documenting an entry for audit review.

Prepare journal entries with proper debits, credits, and supporting documentation for month-end close. Use when booking accruals, prepaid amortization, fixed asset depreciation, payroll entries, revenue recognition, or any manual journal entry.

Generate financial statements (income statement, balance sheet, cash flow) with period-over-period comparison and variance analysis. Use when preparing a monthly or quarterly P&L, closing the books and need to flag material variances, comparing actuals to budget, building a financial summary for leadership review, or looking up GAAP presentation requirements and period-end adjustments.

Manage the month-end close process with task sequencing, dependencies, and status tracking. Use when planning the close calendar, tracking close progress, identifying blockers, or sequencing close activities by day.

Support SOX 404 compliance with control testing methodology, sample selection, and documentation standards. Use when generating testing workpapers, selecting audit samples, classifying control deficiencies, or preparing for internal or external audits.

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.

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 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.

Performs financial ratio analysis, DCF valuation, budget variance analysis, and rolling forecast construction for strategic decision-making. Use when analyzing financial statements, building valuation models, assessing budget variances, or constructing financial projections and forecasts. Also applicable when users mention financial modeling, cash flow analysis, company valuation, financial projections, or spreadsheet analysis.