Skills for your AI
Researches, monitors, audits and reports on purchasing regulatory compliance, covering supplier assessments, documentation, training, policies, KPIs and regulatory reporting. Use when a purchasing manager needs regulatory requirements, supplier compliance chec
Identifies, assesses, mitigates, monitors, and communicates QA risks using provided data, producing risk registers, mitigation plans, reports, and stakeholder communications. Use when a QA manager needs risk analysis for a release or process, mitigation or res
Analyzes compliance data, builds compliance reports, tracks non-compliance trends, reviews policies, evaluates training, preps audits, manages compliance documents and monitoring tools. Use when a quality control specialist needs compliance findings, reports,
Manages ISO 13485 audit programs, executes audits, classifies findings, drives CAPA and external audit readiness, and maintains auditor competency. Use when planning audit schedules, conducting internal or supplier audits, handling nonconformities and CAPAs, p
Supports quality audits by analyzing quality data, checking compliance, reviewing records, performing root cause analysis, and drafting corrective action plans, checklists, and reports. Use when quality control data, audit findings, feedback, KPIs, or document
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use when working on document control procedures, change control workflows, document numbering, version mana
Manages document control, change control, and regulatory documentation compliance for medical device organizations. Use when designing document control systems, reviewing technical files for EU MDR/FDA/ISO compliance, handling change requests, auditing documen
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. Use when lea
Oversees quality system governance, regulatory compliance, management reviews, KPIs, audits, and certifications for HealthTech and MedTech companies. Use when asked about QMS effectiveness, compliance status, management review prep, KPI dashboards, quality str
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
Supports the full environmental impact assessment workflow—data collection, impact analysis, stakeholder engagement, compliance, reporting, risk and mitigation, monitoring, predictive modeling, tooling, and public awareness. Use when working on EIA data, repor
Researches, interprets, documents, monitors, audits, and trains on R&D regulatory requirements. Use when the user needs applicable regulations summarized, hard regulatory text simplified, compliance documents drafted, regulatory changes monitored, audit checkl
Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing).
Guides authorized testers through enumerating race-prone endpoints, designing synchronized race payloads, analyzing responses, verifying state impact, and documenting reproducible race condition findings. Use when testing web applications for race conditions,
Supports real estate brokers with regulatory research, document drafting and review, fair housing and advertising compliance, policy development, due diligence, dispute analysis, privacy and client funds guidance, and compliance training. Use when a broker ask
Organizes, tracks, and coordinates real estate transactions from contract to closing, covering documents, deadlines, communications, tasks, compliance, vendors, reporting, and escrow. Use when a broker needs transaction documents indexed, deadlines tracked, cl
Guides logistics coordinators through installing, configuring, integrating, testing, and optimizing real-time tracking systems for fleets and shipments. Use when setting up tracking software, integrating GPS or temperature sensors, configuring user access and
Guides compliance analysts through organizing, automating, securing, auditing, and governing record-keeping processes, producing plans, templates, checklists, and KPI frameworks. Use when the user asks about record organization, retention and disposal, system
Keeps authorized red-team engagements moving with full surface coverage and minimum-necessary extraction. Use when scope says red team, adversary emulation, assume breach, or TIBER-style, and when handling blockers, findings, coverage sweeps, extraction limits
Formats raw red-team findings into a structured, severity-ranked client report using the six-section finding format and eight-section document structure. Use when a user provides raw red-team observations, needs severity or status assigned, wants impact rewrit
Researches environmental regulations, assesses compliance risks, and drafts permits, impact assessments, waste plans, and audit and training materials. Use when an engineer needs regulatory summaries or monitoring, a compliance gap analysis, a legislative impa
Handles regulatory research, compliance tracking and gap analysis, reporting, audit support, training, correspondence, strategy and advocacy for legal assistants; flags changes to filings, correspondence, and audit materials. Use when the user asks for regulat
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; devel
Provides regulatory strategy, submission management, risk assessment, and compliance tracking for HealthTech and MedTech devices. Use when planning a regulatory pathway, managing an FDA/EU MDR/ISO submission, assessing regulatory risk, drafting authority commu
