Medical Device Quality Management Systems

Strategy and Techniques for Improving Efficiency and Effectiveness
Erscheinungsjahr 2018
ISBN: 978-0-12-814221-9
Verlag: Elsevier Science Publishing Co Inc

Buch, Englisch, 294 Seiten, Format (B × H): 191 mm x 233 mm, Gewicht: 615 g

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.

Autoren/Hrsg.

Manz

Manz, Susanne

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)

Inhaltsverzeichnis

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

Über Autor(innen)

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.