Skill UI

Guides ISO 13485 internal audits for medical device QMS, covering risk-based planning, execution, finding classification, CAPA verification, and readiness for external reviewers.

Document control management for ISO 13485 medical device QMS, covering numbering, lifecycle stages, change control, approvals, and 21 CFR Part 11 compliance to support regulated documentation workflows.

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.

A comprehensive suite of regulatory and quality management skills designed for HealthTech and MedTech organizations. Covers major global standards including ISO 13485, EU MDR, FDA regulations (510(k)/PMA), ISO 27001, and GDPR. Ideal for ensuring product compliance, managing QMS, and performing risk analysis across the product lifecycle.

This comprehensive toolkit assists medical device manufacturers in preparing and auditing documentation for ISO 13485:2016 certification. It guides users through gap analysis of existing Quality Management System (QMS) documentation, provides templates for mandatory procedures (e.g., Quality Manual, CAPA), and offers detailed references to ensure compliance with global standards like FDA QMSR and EU MDR. Use it for full QMS documentation lifecycle management.

A rigorous simulation tool for auditing a medical device's Quality Management System (QMS) against ISO 13485 standards. It forces checks on six critical areas: Design History Files (DHF), CAPA effectiveness, Process Validation, Risk Management, Post-Market Surveillance, and Management Review. Essential for pre-audit, MDR, and FDA QSR alignment.

This skill provides specialized internal auditing capabilities for ISO/IEC 42001:2023 AIMS. It helps compliance teams assess gaps across Clauses 4-10, build comprehensive AI risk registers with control mapping, and plan structured internal audits (Clause 9.2). Ideal for pre-certification readiness, scoping internal audit cycles, or integrating AI systems into existing quality/security management systems (ISMS/QMS).