Validation for Medical Device and Diagnostic Manufacturers PDF Download
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Author: Carol V. Desain
Publisher: CRC Press
ISBN: 1040204384
Category : Medical
Languages : en
Pages : 340
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Book Description
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies
Author: Carol V. Desain
Publisher: CRC Press
ISBN: 1040204384
Category : Medical
Languages : en
Pages : 340
Get Book Here
Book Description
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies
Author: Carol V. Desain
Publisher: CRC Press
ISBN: 9781574910636
Category : Technology & Engineering
Languages : en
Pages : 332
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Book Description
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.
Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
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Book Description
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 you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Author: Anne Booth
Publisher: Routledge
ISBN: 1351413805
Category : Medical
Languages : en
Pages : 430
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Book Description
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 472
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Book Description
Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h
Author: Jose Justiniano
Publisher: CRC Press
ISBN: 0203485742
Category : Science
Languages : en
Pages : 129
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Book Description
Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.
Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420009419
Category : Medical
Languages : en
Pages : 1145
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Book Description
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 0873899334
Category : Business & Economics
Languages : en
Pages : 386
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Book Description
The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Author: Paul H. King
Publisher: CRC Press
ISBN: 1439878072
Category : Medical
Languages : en
Pages : 424
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Book Description
The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This
Author: Gordon Harnack
Publisher: Quality Press
ISBN: 0873898877
Category : Business & Economics
Languages : en
Pages : 488
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Book Description
The number of FDA regulations and the agencys increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firms employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
