
Medical Device Quality Management Systems
Strategy and Techniques for Improving Efficiency and Effectiveness
- 1st Edition - September 27, 2018
- Imprint: Academic Press
- Author: Susanne Manz
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 1 4 2 2 1 - 9
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 1 4 2 2 2 - 6
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulator… Read more
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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
Quality, compliance, and regulatory professionals in medical device companies. Quality engineers, compliance specialists, quality systems professionals, training specialists, CAPA specialists, auditors, project leaders, document control specialists, regulatory specialists, etc. Academics and students in graduate level quality control in medical devices courses
- Edition: 1
- Published: September 27, 2018
- Imprint: Academic Press
- Language: English
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