Quality Management Systems in Medical Devices (ISO 13485)
About Course
Learn how to implement and manage a Quality Management System (QMS) in compliance with ISO 13485 standards, including documentation, CAPA, and audits.
Course Content
Module 1: What are Medical Devices?
Module 2: Classification of Medical Devices
Module 3: Device Lifecycle – Concept to Market
Module 4: Global Regulatory Bodies (FDA, EU MDR, ISO)
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