Medical Device Vigilance: A Comprehensive Visual Guide

This comprehensive visual guide covers the complete landscape of medical device vigilance across seven richly illustrated chapters.

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What’s Inside

Chapter 1 — Taxonomy of Medical Device Safety Events

Classification of device incidents, serious incidents, field safety corrective actions (FSCAs), and the distinction between adverse events and device-related incidents under EU MDR.

Chapter 2 — Expectedness: Risk Analysis vs. Labeling

How risk analysis (ISO 14971), instructions for use, and clinical evaluation reports determine expectedness for medical devices — a fundamentally different approach from pharmaceutical labeling.

Chapter 3 — Causality Assessment Methodology

Device-specific causality frameworks including root cause analysis, fault tree analysis, and the unique challenges of assessing causality for combination products and software as a medical device (SaMD).

Chapter 4 — Signal Detection Frameworks

Trend reporting, vigilance data analysis, and quantitative methods adapted for medical devices including EUDAMED signal detection and post-market surveillance data mining.

Chapter 5 — MIR Workflows

Medical Incident Report workflows from detection through regulatory submission — timelines, minimum data requirements, and the complete reporting chain under EU MDR Article 87.

Chapter 6 — Quality & Vigilance System

Establishing a device vigilance system: the Person Responsible for Regulatory Compliance (PRRC), QMS integration under ISO 13485, CAPA processes, and audit readiness.

Chapter 7 — Resource Compendium

Global device vigilance databases, EU MDR/IVDR references, IMDRF guidelines, MEDDEV guidance documents, and emerging trends in AI-powered device surveillance.