Modern Medical Device Regulation: Volume 1: Overview of Medical Device Regulation: A Core Reliability Perspective and Clinical Engineering Reliability ... Strategy Toolkit for the Right-Sized QMS
Modern Medical Device Regulation, Volume 1, introduces medical device regulation from a core reliability perspective. It explores the connection between clinical engineering reliability and quality management, with emphasis on developing a right-sized QMS strategy for organizations navigating regulatory and operational requirements.
About This Book
This volume provides an overview of medical device regulation with an emphasis on core reliability principles.
It connects regulatory considerations with clinical engineering reliability and quality management strategy.
The book focuses on right-sized quality management systems, offering a framework for thinking about regulatory and operational needs.
Designed as a foundational resource, it addresses the relationship between dependable medical devices, compliance, and structured quality practices.
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