Medical Device Quality Management Systems

Written By Susanne Manz
Medical Device Quality Management Systems
  • Publsiher : Academic Press
  • Release : 27 September 2018
  • ISBN : 0128142227
  • Pages : 294 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Medical Device Quality Management Systems written by Susanne Manz which was release on 27 September 2018, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. 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

Medical Device Quality Management Systems

Medical Device Quality Management Systems
  • Author : Susanne Manz
  • Publisher : Academic Press
  • Release Date : 2018-09-27
  • Total pages : 294
  • ISBN : 0128142227
GET BOOK

Summary : 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 ...

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release Date : 2015-08-18
  • Total pages : 256
  • ISBN : 0128142227
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Summary : Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and ...

Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance
  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release Date : 1998-08-11
  • Total pages : 496
  • ISBN : 0128142227
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Summary : "Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."...

Medical Device Use Error

Medical Device Use Error
  • Author : Michael Wiklund,Andrea Dwyer,Erin Davis
  • Publisher : CRC Press
  • Release Date : 2016-01-06
  • Total pages : 267
  • ISBN : 0128142227
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Summary : Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case ...

Plastics in Medical Devices

Plastics in Medical Devices
  • Author : Vinny R. Sastri
  • Publisher : William Andrew
  • Release Date : 2021-10-01
  • Total pages : 524
  • ISBN : 0128142227
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Summary : Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The ...

The ASQ Certified Medical Device Auditor Handbook Fourth Edition

The ASQ Certified Medical Device Auditor Handbook  Fourth Edition
  • Author : Scott A Laman
  • Publisher : Quality Press
  • Release Date : 2021-02-05
  • Total pages : 372
  • ISBN : 0128142227
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Summary : The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as ...

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma
  • Author : Basem El-Haik,Khalid S. Mekki
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Total pages : 528
  • ISBN : 0128142227
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Summary : The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how ...

ISO 9001 2000 Quality Management System Design

ISO 9001 2000 Quality Management System Design
  • Author : Jay J. Schlickman
  • Publisher : Artech House
  • Release Date : 2003
  • Total pages : 377
  • ISBN : 0128142227
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Summary : "The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and ...

Developing an ISO 13485 Certified Quality Management System

Developing an ISO 13485 Certified Quality Management System
  • Author : Ilkka Juuso
  • Publisher : CRC Press
  • Release Date : 2022-03-21
  • Total pages : 370
  • ISBN : 0128142227
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Summary : Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing ...

Medical Device Software Verification Validation and Compliance

Medical Device Software Verification  Validation and Compliance
  • Author : David A. Vogel
  • Publisher : Artech House
  • Release Date : 2010
  • Total pages : 444
  • ISBN : 0128142227
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Summary : HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps ...

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
  • Author : Jack Wong,Raymond Tong
  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Total pages : 620
  • ISBN : 0128142227
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Summary : Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful ...

Excellence Beyond Compliance

Excellence Beyond Compliance
  • Author : William I. White
  • Publisher : Taylor & Francis
  • Release Date : 2018-05-16
  • Total pages : 216
  • ISBN : 0128142227
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Summary : Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation ...

Healthcare Technology Management A Systematic Approach

Healthcare Technology Management     A Systematic Approach
  • Author : Francis Hegarty,John Amoore,Paul Blackett,Justin McCarthy,Richard Scott
  • Publisher : CRC Press
  • Release Date : 2017-01-06
  • Total pages : 543
  • ISBN : 0128142227
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Summary : Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and ...

Introduction to Medical Software

Introduction to Medical Software
  • Author : Xenophon Papademetris,Ayesha N. Quraishi,Gregory P. Licholai
  • Publisher : Cambridge University Press
  • Release Date : 2022-04-30
  • Total pages : 350
  • ISBN : 0128142227
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Summary : A concise and accessible overview of the design, implementation and management of medical software....

Design Controls for the Medical Device Industry Second Edition

Design Controls for the Medical Device Industry  Second Edition
  • Author : Marie B. Teixeira
  • Publisher : CRC Press
  • Release Date : 2013-11-12
  • Total pages : 205
  • ISBN : 0128142227
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Summary : The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the ...