Medical Device Quality Management Systems. Strategy and Techniques for Improving Efficiency and Effectiveness

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

Authors

Susanne Manz Medical Devices Consultant, MBA, MBB, RAC, CQA. 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.