Medical Device Quality Management Systems

  • Author : Susanne Manz
  • Publsiher : Academic Press
  • Release : 27 September 2018
  • ISBN : 9780128142226
  • Page : 294 pages
  • Rating : 4/5 from 21 voters

Download or read online book entitled Medical Device Quality Management Systems written by Susanne Manz and published by Academic Press. This book was released on 27 September 2018 with total page 294 pages. Available in PDF, EPUB and Kindle. Get best books that you want by click Get Book Button and Read as many books as you like. Book Excerpt : 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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