Medical Device Quality Management Systems

  • ID: 4519411
  • Book
  • 300 Pages
  • Elsevier Science and Technology
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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
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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

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Manz, Susanne
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.
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown