Design Controls for the Medical Device Industry, Second Edition

Design Controls for the Medical Device Industry, Second Edition

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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 companya€™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 todaya€™s third-party auditor/investigator expectations and saves you valuable time and money. The authora€™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.An example of a completed Product Claims Sheet for tracheostomy tubes is indicated in Figure 6.1. ... will be required for your device, for example, product label, carton label, shipping label, instructions for use, operating manual, and so on. ... search to make sure that you are not infringing on any existing patents or trademarks and, if not, initiate the application and/or registration process as needed.

Title:Design Controls for the Medical Device Industry, Second Edition
Author: Marie B. Teixeira
Publisher:CRC Press - 2013-11-12

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