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Author : Shawn Schmitt
Publisher :
ISBN 13 : 9781947493889
Total Pages : 0 pages
Book Rating : 4.84/5 ( download)
Download or read book The Medical Device Validation Handbook, Third Edition written by Shawn Schmitt and published by . This book was released on 2023-08-18 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Robert Packard
Publisher :
ISBN 13 : 9780967311524
Total Pages : 258 pages
Book Rating : 4.27/5 ( download)
Download or read book The Medical Device Validation Handbook written by Robert Packard and published by . This book was released on 2015-04-05 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference text on validation processes for manufacturing medical devices.
Author : Max Sherman
Publisher :
ISBN 13 : 9781947493094
Total Pages : pages
Book Rating : 4.94/5 ( download)
Download or read book The Medical Device Validation Handbook, Second Edition written by Max Sherman and published by . This book was released on 2018-06-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.38/5 ( download)
Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Vernon Geckler
Publisher : Wasatch Consulting Resources LLC
ISBN 13 : 0692835415
Total Pages : 441 pages
Book Rating : 4.18/5 ( download)
Download or read book DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
Author : Priscilla Browne
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781548341442
Total Pages : 232 pages
Book Rating : 4.44/5 ( download)
Download or read book The Validation Handbook for Engineers written by Priscilla Browne and published by Createspace Independent Publishing Platform. This book was released on 2017-06-23 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation is a regulatory and legal requirement for the manufacture of medical devices and medicinal products. Validation is concerned with ensuring design requirements are fulfilled and that products are safely and consistently manufactured. It is a systematic and logical process. This book provides a concise overview and reference for engineers. It includes chapters on equipment and process validation and test method validation. Ancillary services and facilities are also reviewed in terms of typical deliverables.
Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1000693872
Total Pages : 795 pages
Book Rating : 4.74/5 ( download)
Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1000696952
Total Pages : 491 pages
Book Rating : 4.50/5 ( download)
Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 491 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.13/5 ( download)
Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Author : Emmet Tobin, Mr.
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781977834010
Total Pages : 242 pages
Book Rating : 4.19/5 ( download)
Download or read book Process Validation for Medical Devices written by Emmet Tobin, Mr. and published by Createspace Independent Publishing Platform. This book was released on 2017-09-29 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: At over 200 pages, this pocket book will bring you up to speed quickly on the requirements of process validation. It is divided into logical chapters that sets out the journey of validation in a clear fashion. Many components of Validation for medical devices are transferable. Understanding the fundamental principles of validation allows the reader to apply them to different products and different manufacturing processes. This book is ideal for professionals new to Process Validation. Although it has a practical approach, it is also suited to the academic. Chapter 1: Validation Planning, Chapter 2: Facilities And Utilities Qualification Chapter 3: Equipment And Software Validation Chapter 4: Process Validation Chapter 5: Packaging Validation Chapter 6: Test Method Validation Chapter 7: Measurement Chapter 8: ISO 13485 Chapter 9: Lean
