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...

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Main Authors: Manz, Susanne, author 649846, ScienceDirect (Online service) 7722
Format: software, multimedia
Language:eng
Published: London : Academic Press, 2018
Subjects:
Online Access:https://www.sciencedirect.com/book/9780128142219
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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.
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institution Universiti Teknologi Malaysia - OCEAN
language eng
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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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