Agent Skills Directory

Monitors customer health, predicts churn risk, and identifies expansion opportunities using weighted scoring models for SaaS customer success. Use when analyzing customer accounts, reviewing retention metrics, scoring at-risk customers, or when the user mentions churn, customer health scores, upsell opportunities, expansion revenue, retention analysis, or customer analytics. Runs three Python CLI tools to produce deterministic health scores, churn risk tiers, and prioritized expansion recommendations across Enterprise, Mid-Market, and SMB segments.

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.

Multi-source research on a customer question or topic with source attribution. Use when a customer asks something you need to look up, investigating whether a bug has been reported before, checking what was previously told to a specific account, or gathering background before drafting a response.

Draft a knowledge base article from a resolved issue or common question. Use when a ticket resolution is worth documenting for self-service, the same question keeps coming up, a workaround needs to be published, or a known issue should be communicated to customers.

Package an escalation for engineering, product, or leadership with full context. Use when a bug needs engineering attention beyond normal support, multiple customers report the same issue, a customer is threatening to churn, or an issue has sat unresolved past its SLA.

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.

Draft a professional customer-facing response tailored to the situation and relationship. Use when answering a product question, responding to an escalation or outage, delivering bad news like a delay or won't-fix, declining a feature request, or replying to a billing issue.

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

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.

Triage and prioritize a support ticket or customer issue. Use when a new ticket comes in and needs categorization, assigning P1-P4 priority, deciding which team should handle it, or checking whether it's a duplicate or known issue before routing.

GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.

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.