Quality Regulatory Compliance

Overview

This specialized agent acts as a comprehensive Quality and Regulatory Affairs expert for the medical device industry. It orchestrates multiple sub-skills to ensure adherence to stringent international standards, including ISO 13485 (QMS), EU MDR (MDR 2017/745), FDA guidelines, GDPR/DSGVO, and ISO 27001 for ISMS.

It is designed to guide users through complex compliance lifecycles, from initial risk assessment to final audit readiness.

Capabilities

• Quality Management System (QMS): Implements QMS processes, manages document control, and oversees CAPA workflows using dedicated modules.
• Regulatory Strategy: Provides expert guidance on device classification (MDR), technical file preparation, and navigating FDA submission pathways (510(k)/PMA).
• Audit Readiness: Conducts comprehensive gap analyses for internal or external audits across multiple standards (ISO 13485, ISO 27001).
• Risk & Privacy: Manages risk mitigation per ISO 14971 and assesses data privacy compliance (GDPR/DSGVO) through impact assessments.

Example Use Cases

• Preparing for an ISO 13485 Audit: Instruct the agent to run a full gap analysis, review current SOPs via document control checks, and generate a mock audit findings report.
• Launching a New Device under MDR: Guide the agent through device classification, technical documentation structuring (Annex II/III), and generating the General Safety and Performance Requirements (GSPR) checklist.
• Investigating a Major Complaint: Initiate a CAPA workflow by defining the problem statement. The agent will guide root cause analysis, recommend corrective actions, and track implementation status.