Medical Device Quality Management Systems - 1st Edition - ISBN: 9780128142219, 9780128142226

Medical Device Quality Management Systems

1st Edition

Strategy and Techniques for Improving Efficiency and Effectiveness

Authors: Susanne Manz
eBook ISBN: 9780128142226
Paperback ISBN: 9780128142219
Imprint: Academic Press
Published Date: 1st October 2018
Page Count: 294
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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.

Key Features

  • 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

Table of Contents

Part 1: An Effective Quality System
1. Regulatory requirements
2. Increasing Expectations
3. Establish and Maintain
4. QMS Structure

Part 2: An Efficient Quality Management System
5. Shifting from Cost of Quality to Value of Quality
6. Avoiding Common mistakes

Part 3:  Roles, Responsibilities, Capabilities
7. Quality is Not an Organization
8. Roles: Management Representative
9. Management with Executive Responsibility
10. Process Ownership
11. Capabilities:
Measure – Metrics and Dashboards
Embrace- Culture and Value
Identify – Inspection, Audit, Process Control, etc.
Fix – CAPA, Six Sigma, and more
Prioritize – Risk Management, Residual Risk
Control – Monitor and Control
Share and Communicate – Management Review and Transparency

Part 4:  Quality Leadership and a Seat at the Table
12. Value of Quality
13. Maturity Modeling in Medical Device Companies

Part 5:  Vision, Strategy, Quality Planning
14. Compelling Vision
15. Alignment
16. Translating vision to plans

Part 6:  Improvement: Tools and Techniques
17. CAPA
18. Six Sigma


No. of pages:
© Academic Press 2019
Academic Press
eBook ISBN:
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About the Author

Susanne Manz

The author is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma and 30 years’ experience in the field. She has worked at industry leading companies such as GE, Johnson and Johnson, and Medtronic. Susanne has an extensive background in quality and compliance for medical devices throughout the product lifecycle from engineering and new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. She has served as a judge for ASQ ITEA awards program. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. She has conducted countless webinars, seminars, and training sessions to help companies improve their quality and compliance results.

Affiliations and Expertise

Medical Devices Consultant, MBA, MBB, RAC, CQA

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