Skill UI

Provides FDA regulatory guidance for medical device manufacturers encompassing pathway strategy for 510(k)/PMA/De Novo submissions, QSR compliance, HIPAA assessments, and cybersecurity planning to support premarket filings.

Automates compliance and security audit reporting for standards such as PCI DSS, HIPAA, SOC 2, and ISO 27001 by using the compliance-report-generator plugin to collect details, format documentation, and streamline regulatory proof.

Configure robust role-based access control (RBAC) for Granola workspaces, essential for enterprise-level data security and governance. This guide details setting up role hierarchies (Owner, Admin, Member, Viewer), defining granular permissions, integrating SSO/SCIM for automated provisioning, and implementing least-privilege access principles. It also covers advanced features like per-workspace sharing policies and detailed audit logging to ensure regulatory compliance.

Defines the Senior Quality Manager Responsible Person (QMR) role for HealthTech/MedTech firms, covering ISO 13485 Clause 5.5.2 responsibilities, management review workflows, and KPI-driven compliance governance to ensure QMS effectiveness and regulatory accountability.

Implements and maintains ISO 13485 QMS for medical device organizations, covering gap analysis, documentation control, internal audits, supplier qualification, and CAPA tracking to keep regulatory programs audit-ready.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

This skill acts as a specialized domain intelligence strategist, capable of analyzing specific industry niches (e.g., Fintech, HealthTech). It goes beyond general functionality to inject crucial domain-specific knowledge, mandatory regulatory compliance (like HIPAA or GDPR), and industry-leading UX/UI patterns. Essential for ensuring the product is optimized for its vertical market.

A comprehensive framework for global expansion, guiding businesses through market selection, evaluating entry modes (export, partnership, subsidiary), and executing localization strategies. Covers product adaptation, go-to-market planning, regulatory compliance, and operational setup for new international regions.

Plans and facilitates ransomware tabletop exercises that stress-test organizational readiness, decision-making, and communication during simulated LockBit/ALPHV/Cl0p incidents. Injects cover double-extortion, backup destruction, and regulatory notifications, while scoring participant choices against NIST CSF and CISA guidance.

Delivers MiCA compliance evidence plus stablecoin risk scoring using FeedOracle’s MCP tools, ideal for audit or regulatory queries needing signed, verifiable data and pegged-asset insights.

This skill performs comprehensive regulatory gap analysis across major compliance frameworks, including GDPR, CCPA, ADA, PCI-DSS, and CAN-SPAM. It analyzes live websites and codebases to produce a detailed compliance scorecard, identifies specific non-compliant gaps, and generates a prioritized remediation roadmap with effort estimates. Essential for businesses ensuring legal adherence across multiple global jurisdictions.

A comprehensive checklist to guide businesses through year-end financial closing, tax preparation, and compliance filing. It verifies the synchronization of data from banking, payroll, and expense platforms, ensuring all integrations are active, records are reconciled, and regulatory requirements are met to prevent missed deadlines or audit risks.