Agent Skills Directory

Apply statistical methods including descriptive stats, trend analysis, outlier detection, and hypothesis testing. Use when analyzing distributions, testing for significance, detecting anomalies, computing correlations, or interpreting statistical results.

Analyze and improve business processes. Trigger with "this process is slow", "how can we improve", "streamline this workflow", "too many steps", "bottleneck", or when the user describes an inefficient process they want to fix.

Convert laboratory instrument output files (PDF, CSV, Excel, TXT) to Allotrope Simple Model (ASM) JSON format or flattened 2D CSV. Use this skill when scientists need to standardize instrument data for LIMS systems, data lakes, or downstream analysis. Supports auto-detection of instrument types. Outputs include full ASM JSON, flattened CSV for easy import, and exportable Python code for data engineers. Common triggers include converting instrument files, standardizing lab data, preparing data for upload to LIMS/ELN systems, or generating parser code for production pipelines.

Operations leadership for scaling companies. Process design, OKR execution, operational cadence, and scaling playbooks. Use when designing operations, setting up OKRs, building processes, scaling teams, analyzing bottlenecks, planning operational cadence, or when user mentions COO, operations, process improvement, OKRs, scaling, operational efficiency, or execution.

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

Create or update an operational runbook for a recurring task or procedure. Use when documenting a task that on-call or ops needs to run repeatably, turning tribal knowledge into exact step-by-step commands, adding troubleshooting and rollback steps to an existing procedure, or writing escalation paths for when things go wrong.

Document a business process — flowcharts, RACI, and SOPs. Use when formalizing a process that lives in someone's head, building a RACI to clarify who owns what, writing an SOP for a handoff or audit, or capturing the exceptions and edge cases of how work actually gets done.

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.

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.

Answer data questions -- from quick lookups to full analyses. Use when looking up a single metric, investigating what's driving a trend or drop, comparing segments over time, or preparing a formal data report for stakeholders.

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.

Build an interactive HTML dashboard with charts, filters, and tables. Use when creating an executive overview with KPI cards, turning query results into a shareable self-contained report, building a team monitoring snapshot, or needing multiple charts with filters in one browser-openable file.