Medical Device Quality Management Systems

• Author : Susanne Manz
• Publisher : Academic Press
• Release Date : 2018-09-27
• Total pages : 294
• ISBN : 0128142227

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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 ...

• Author : Brendan Cooper
• Publisher : Createspace Independent Publishing Platform
• Release Date : 2017-04-14
• Total pages : 130
• ISBN : 0128142227

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Summary : This concise book is broadly divided into 3 manageable parts. The first part introduces the standard ISO 13485 and the basics of Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, an overview of Quality Risk management is provided. In the ...

• Author : Amiram Daniel
• Publisher : Quality Press
• Release Date : 2008-01-01
• Total pages : 304
• ISBN : 0128142227

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Summary : How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well ...

• Author : Itay Abuhav
• Publisher : CRC Press
• Release Date : 2018-05-11
• Total pages : 878
• ISBN : 0128142227

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Summary : This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the ...

• Author : Itay Abuhav
• Publisher : CRC Press
• Release Date : 2017-02-17
• Total pages : 428
• ISBN : 0128142227

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Summary : What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you ...

• 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 ...

• 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 ...

• 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."...

• 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 ...

• 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 ...

• 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 ...

• 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 ...

• 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 ...

• 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 ...

• Author : David N. Muchemu
• Publisher : AuthorHouse
• Release Date : 2008-04-07
• Total pages : 132
• ISBN : 0128142227

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Summary : Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical,Biomedical,and Medical Device companies.This book does the following for you: 1.It helps Managers in Startup companies design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for ...