Design Controls For The Medical Device Industry

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Design Controls for the Medical Device Industry, Third Edition

Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 1351261460
Total Pages : 185 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Design Controls for the Medical Device Industry, Third Edition by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry, Third Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2019-08-02 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements

Design Controls for the Medical Device Industry

Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 0824743555
Total Pages : 253 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie B. Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Design Controls for the Medical Device Industry, Second Edition

Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 1466503548
Total Pages : 208 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Design Controls for the Medical Device Industry, Second Edition by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry, Second Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2013-11-12 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

Design Controls for the Medical Device Industry

Author : Marie Teixeira
Publisher :
ISBN 13 : 9780429221835
Total Pages : 254 pages
Book Rating : 4.2/5 (218 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by . This book was released on 2002 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.Details procedures utilize.

DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

Author : Vernon Geckler
Publisher : Wasatch Consulting Resources LLC
ISBN 13 : 0692835415
Total Pages : 441 pages
Book Rating : 4.6/5 (928 download)

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Book Synopsis DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS by : Vernon Geckler

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.

Medical Device Design and Regulation

Author : Carl T. DeMarco
Publisher : Quality Press
ISBN 13 : 0873898168
Total Pages : 369 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Medical Device Design and Regulation by : Carl T. DeMarco

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Design Controls for the Medical Device Industry

Author : Marie Teixeira
Publisher : CRC Press
ISBN 13 : 9780203909386
Total Pages : 258 pages
Book Rating : 4.9/5 (93 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Medical Device Design and Regulation

Author : Carl T. DeMarco
Publisher : Quality Press
ISBN 13 : 0873891880
Total Pages : 369 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Medical Device Design and Regulation by : Carl T. DeMarco

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-24 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

Principles of Design Controls for Medical Device

Author : David N. Muchemu
Publisher : CreateSpace
ISBN 13 : 9781470173661
Total Pages : 102 pages
Book Rating : 4.1/5 (736 download)

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Book Synopsis Principles of Design Controls for Medical Device by : David N. Muchemu

Download or read book Principles of Design Controls for Medical Device written by David N. Muchemu and published by CreateSpace. This book was released on 2012-03-01 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Refence book for Quality Engineers, Quality Managers, and Design Engineers in the medical device industry

Medical Device Design

Author : Peter J. Ogrodnik
Publisher : Academic Press
ISBN 13 : 0128149639
Total Pages : 538 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Medical Device Design by : Peter J. Ogrodnik

Download or read book Medical Device Design written by Peter J. Ogrodnik and published by Academic Press. This book was released on 2019-10-30 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Six Sigma for Medical Device Design

Author : Jose Justiniano
Publisher : CRC Press
ISBN 13 : 0203485742
Total Pages : 152 pages
Book Rating : 4.2/5 (34 download)

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Book Synopsis Six Sigma for Medical Device Design by : Jose Justiniano

Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Medical Device Design for Six Sigma

Author : Basem El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118210417
Total Pages : 528 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Medical Device Design for Six Sigma by : Basem El-Haik

Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Medical Device Software Verification, Validation and Compliance

Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.5/5 (969 download)

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Book Synopsis Medical Device Software Verification, Validation and Compliance by : David A. Vogel

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."

Design Controls for the Medical Device Industry

Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 1466503556
Total Pages : 196 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie B. Teixeira and published by CRC Press. This book was released on 2013-11-12 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 development of an effectiv

Class 1 Devices

Author : Peter J Ogrodnik
Publisher : Academic Press
ISBN 13 : 0128007966
Total Pages : 114 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Class 1 Devices by : Peter J Ogrodnik

Download or read book Class 1 Devices written by Peter J Ogrodnik and published by Academic Press. This book was released on 2014-11-24 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes. Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products. Joins up theory and practice in an accessible style.