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

Medical Devices Quality Strategy and Planning: Create an Efficient and Effective Quality Management System in Medical Device Companies 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 SystemPresents a roadmap for QMS developmentCovers techniques to assess current stateIncludes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans INDICE: 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

• ISBN: 978-0-12-814221-9
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 300
• Fecha Publicación: 01/10/2018
• Nº Volúmenes: 1
• Idioma: Inglés