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Author | : Marie B. Teixeira |
Publisher | : CRC Press |
Total Pages | : 185 |
Release | : 2019-08-02 |
Genre | : Medical |
ISBN | : 1351261460 |
Download Design Controls for the Medical Device Industry, Third Edition Book in PDF, ePub and Kindle
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
Author | : Marie B. Teixeira |
Publisher | : |
Total Pages | : |
Release | : 2013 |
Genre | : Medical instruments and apparatus |
ISBN | : 9781628707120 |
Download Design Controls for the Medical Device Industry Book in PDF, ePub and Kindle
"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. The book also addresses device risk and classification, and covers risk management in its own chapter. Appendices have also been revised"--Provided by publisher.
Author | : Marie B. Teixeira |
Publisher | : CRC Press |
Total Pages | : 208 |
Release | : 2013-11-12 |
Genre | : Medical |
ISBN | : 1466503548 |
Download Design Controls for the Medical Device Industry, Second Edition Book in PDF, ePub and Kindle
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.
Author | : Marie Teixeira |
Publisher | : CRC Press |
Total Pages | : 258 |
Release | : 2002-09-20 |
Genre | : Medical |
ISBN | : 9780203909386 |
Download Design Controls for the Medical Device Industry Book in PDF, ePub and Kindle
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
Author | : Vernon Geckler |
Publisher | : Wasatch Consulting Resources LLC |
Total Pages | : 441 |
Release | : 2017-02-11 |
Genre | : |
ISBN | : 0692835415 |
Download DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Book in PDF, ePub and Kindle
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 | : Marie Teixeira |
Publisher | : |
Total Pages | : 254 |
Release | : 2002 |
Genre | : TECHNOLOGY & ENGINEERING |
ISBN | : 9780429221835 |
Download Design Controls for the Medical Device Industry Book in PDF, ePub and Kindle
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.
Author | : |
Publisher | : Academic Press |
Total Pages | : 369 |
Release | : 2012-12-17 |
Genre | : Technology & Engineering |
ISBN | : 0123919436 |
Download Medical Device Design Book in PDF, ePub and Kindle
This book 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. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Author | : Itay Abuhav |
Publisher | : CRC Press |
Total Pages | : 735 |
Release | : 2018-05-11 |
Genre | : Medical |
ISBN | : 1351000772 |
Download ISO 13485:2016 Book in PDF, ePub and Kindle
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author | : Carl T. DeMarco |
Publisher | : Quality Press |
Total Pages | : 369 |
Release | : 2011-01-01 |
Genre | : Business & Economics |
ISBN | : 0873898168 |
Download Medical Device Design and Regulation Book in PDF, ePub and Kindle
Author | : Theodore R. Kucklick |
Publisher | : CRC Press |
Total Pages | : 513 |
Release | : 2012-12-05 |
Genre | : Medical |
ISBN | : 143981189X |
Download The Medical Device R&D Handbook, Second Edition Book in PDF, ePub and Kindle
Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.