Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness /
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...
| Main Authors: | , |
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| Format: | software, multimedia |
| Language: | eng |
| Published: |
London : Academic Press,
2018
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| Subjects: | |
| Online Access: | https://www.sciencedirect.com/book/9780128142219 |
| _version_ | 1826472676642783232 |
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| author | Manz, Susanne, author 649846 ScienceDirect (Online service) 7722 |
| author_facet | Manz, Susanne, author 649846 ScienceDirect (Online service) 7722 |
| author_sort | Manz, Susanne, author 649846 |
| collection | OCEAN |
| description | 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. |
| first_indexed | 2024-03-05T17:21:58Z |
| format | software, multimedia |
| id | KOHA-OAI-TEST:607134 |
| institution | Universiti Teknologi Malaysia - OCEAN |
| language | eng |
| last_indexed | 2024-03-05T17:21:58Z |
| publishDate | 2018 |
| publisher | London : Academic Press, |
| record_format | dspace |
| spelling | KOHA-OAI-TEST:6071342023-09-15T13:55:57ZMedical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / Manz, Susanne, author 649846 ScienceDirect (Online service) 7722 software, multimedia Electronic books 631902 London : Academic Press,2018©2019engMedical 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.Includes index.Chapter 1 - Regulatory requirements -- Chapter 2 - Increasing expectations -- Chapter 3 - Establish and maintain -- Chapter 4 - QMS structure -- Chapter 5 - Waste and inefficiency in the quality management system -- Chapter 6 - Avoiding common mistakes -- Chapter 7 - Quality is not an organization -- Chapter 8 - Capabilities and MEDICS for an effective QMS -- Chapter 9 - Compliance must result in improved quality -- Chapter 10 - Shifting from cost of quality to the value proposition -- Chapter 11 - Maturity modeling in medical device companies -- Chapter 12 - Compelling vision -- Chapter 13 - Translating QMS vision to strategic quality objectives and plans -- Chapter 14 - Alignment -- Chapter 15 - Alphabet soup -- Chapter 16 - FDA inspection preparedness -- Chapter 17 - Conclusion -- References -- IndexMedical 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.Total quality managementMedical instruments and apparatushttps://www.sciencedirect.com/book/9780128142219URN:ISBN:9780128142219Remote access restricted to users with a valid UTM ID via VPN. |
| spellingShingle | Total quality management Medical instruments and apparatus Manz, Susanne, author 649846 ScienceDirect (Online service) 7722 Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / |
| title | Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / |
| title_full | Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / |
| title_fullStr | Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / |
| title_full_unstemmed | Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / |
| title_short | Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness / |
| title_sort | medical device quality management systems strategy and techniques for improving efficiency and effectiveness |
| topic | Total quality management Medical instruments and apparatus |
| url | https://www.sciencedirect.com/book/9780128142219 |
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