Guidelines for Failure Modes and Effects Analysis for Medical Devices

Presents guidelines that focus on failure modes and effects analysis (FMEA) and its application throughout the life cycle of a medical device. This book outlines the major US and EU standards and regulations. It presents an overview of risk management and risk analysis methodologies, and common FMEA pitfalls.

Prezinta linii directoare care se concentreaza pe modurile de defectiune si analiza efectelor (FMEA) si aplicarea acesteia pe parcursul ciclului de viata al unui dispozitiv medical. Aceasta carte prezinta principalele standarde si reglementari din SUA si UE.