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ISBN :9781439866115
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File Size : 79.27 MB
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Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.
ISBN :9781351000772
Genre :Medical
File Size : 38.90 MB
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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 documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version.
ISBN :9780873898461
Genre :Business & Economics
File Size : 68.33 MB
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'Management Guidance, Implementation Support, Documentation Assistance, Auditing Technique.'
ISBN :OCLC:1058947773
Genre :Medical instruments and apparatus
File Size : 52.50 MB
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ISBN :9780081002919
Genre :Medical
File Size : 50.23 MB
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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 processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process
ISBN :OCLC:948781258
Genre :
File Size : 83.73 MB
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ISBN :9780873898362
Genre :Business & Economics
File Size : 41.82 MB
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This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.
ISBN :0580456447
Genre :Medical instruments and apparatus
File Size : 54.75 MB
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Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Quality, Acceptance (approval), Quality auditing, Management Quality and Management
ISBN :OCLC:1061848205
Genre :
File Size : 84.84 MB
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ISBN :1534675272
Genre :
File Size : 21.40 MB
Format :PDF, Kindle
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This short concise book provides an introduction to ISO 13485. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket. ISO 13485 is the Quality management standard of choice for manufactures of medical devices. Revised in 2016, ISO 13485:2016 'specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.'1 The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services. (Page count 86 pages)
Iso 13485
Author :Itay AbuhavISBN :9781439866115
Genre :
Revision of ISO 13528: Statistical Methods for Proficiency Testing by Interlaboratory Comparison 8th Eurachem PT Workshop 7 October, 2014 Daniel Tholen, M.S. Traverse City, MI Revision of ISO 13528 ISO TC69 –SC6 WG9 Revision process –CD & DIS Ballots –FDIS Major changes from current version.
MedicalFile Size : 79.27 MB
Format :PDF
Download :133
Read :1073
Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.
Iso 13485 2016
Author :Itay AbuhavISBN :9781351000772
Genre :Medical
File Size : 38.90 MB
Format :PDF, Mobi
Download :900
Read :947
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 documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version.
A Practical Field Guide For Iso 13485
Author :Erik V. MyhrbergISBN :9780873898461
Genre :Business & Economics
File Size : 68.33 MB
Format :PDF, ePub, Mobi
Download :701
Read :714
'Management Guidance, Implementation Support, Documentation Assistance, Auditing Technique.'
Iso 13485 2016
Author :ISBN :OCLC:1058947773
Genre :Medical instruments and apparatus
File Size : 52.50 MB
Format :PDF, ePub, Mobi
Download :771
Read :370
Medical Devices
Author :Seeram RamakrishnaISBN :9780081002919
Genre :Medical
File Size : 50.23 MB
Format :PDF
Download :681
Read :931
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 processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process
Iso 13485 2016 Medical Devices Quality Management Systems Requirements For Regulatory Purposes
Author :ISBN :OCLC:948781258
Genre :
File Size : 83.73 MB
Format :PDF, ePub, Docs
Download :647
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The Biomedical Quality Auditor Handbook Second Edition
Author :ASQ Biomedical DivisionISBN :9780873898362
Genre :Business & Economics
File Size : 41.82 MB
Format :PDF, ePub
Download :990
Read :408
This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.
Medical Devices
Author :George Dennis GreenISBN :0580456447
Genre :Medical instruments and apparatus
File Size : 54.75 MB
Format :PDF, Mobi
Download :409
Read :548
Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Quality, Acceptance (approval), Quality auditing, Management Quality and Management
Une En Iso 13485 2018
Author :ISBN :OCLC:1061848205
Genre :
File Size : 84.84 MB
Format :PDF, Kindle
Download :976
Read :671
Iso 13485 Starter Guide
Author :Emmet TobinISBN :1534675272
Genre :
File Size : 21.40 MB
Format :PDF, Kindle
Download :591
Read :1161
This short concise book provides an introduction to ISO 13485. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket. ISO 13485 is the Quality management standard of choice for manufactures of medical devices. Revised in 2016, ISO 13485:2016 'specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.'1 The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services. (Page count 86 pages)