Medical device quality management systems : strategy and techniques for improving efficiency and effectiveness /

Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management...

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Bibliographic Details
Main Author: Manz, Susanne (Author)
Corporate Author: ScienceDirect (Online service)
Format: eBook
Language:English
Published: London, United Kingdom : Academic Press, an imprint of Elsevier, [2019]
Subjects:
Online Access:Connect to the full text of this electronic book
Description
Summary:Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.- Provides practical, real-world guidance on developing an effective and efficient Quality Management System- Presents a roadmap for QMS development- Covers techniques to assess current state- Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans.
Physical Description:1 online resource
ISBN:0128142219
9780128142219
9780128142226
0128142227