Medical Device Quality Management Systems
Strategy and Techniques for Improving Efficiency and Effectiveness
- 1st Edition - October 2, 2018
- 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
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
Part 1: An Effective Quality System1. Regulatory requirements 2. Increasing Expectations3. Establish and Maintain4. QMS Structure
Part 2: An Efficient Quality Management System5. Shifting from Cost of Quality to Value of Quality6. Avoiding Common mistakes
Part 3: Roles, Responsibilities, Capabilities7. Quality is Not an Organization8. Roles: Management Representative9. Management with Executive Responsibility10. Process Ownership11. Capabilities:Measure – Metrics and DashboardsEmbrace- Culture and ValueIdentify – Inspection, Audit, Process Control, etc.Fix – CAPA, Six Sigma, and morePrioritize – Risk Management, Residual RiskControl – Monitor and ControlShare and Communicate – Management Review and Transparency
Part 4: Quality Leadership and a Seat at the Table12. Value of Quality13. Maturity Modeling in Medical Device Companies
Part 5: Vision, Strategy, Quality Planning14. Compelling Vision15. Alignment16. Translating vision to plans
Part 6: Improvement: Tools and Techniques17. CAPA18. Six Sigma
- Edition: 1
- Published: October 2, 2018
- Language: English
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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, CQARead Medical Device Quality Management Systems on ScienceDirect