Design Controls for the Medical Device Industry, Third Edition (English Edition) 3第三 版本, Kindle电子书
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
- ASIN : B07VWYLPJ5
- 出版社 : CRC Press; 第 3rd 版 (2019年8月2日)
- 出版日期 : 2019年8月2日
- 语言 : 英语
- 文件大小 : 7332 KB
- 同步设备使用情况： : 根据出版商限制，最多 4 台同步设备
- 标准语音朗读 : 未启用
- X-Ray : 未启用
- 生词提示功能 : 未启用
- 纸书页数 : 262页
- 亚马逊热销商品排名: 商品里排第240,530名Kindle商店 (查看Kindle商店商品销售排行榜)
- 商品里排第878名Engineering & Technology（工程与技术）
- 商品里排第1,459名Science & Nature（科学与自然）
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"Usability testing is a method used to evaluate a device's usability."
Crikey, did anyone edit this book? Isn't an editor supposed to stop you from writing sentences like that? I want insight in a book like this, and there's little to be had. It's generally readable, the material seems accurate enough, but it's pretty low on my list of good technical books. It really seems like someone told the author it needed to be 250 pages, and they had 50 pages of material. This book is the opposite of 10 pounds in a 5 pound bag. I don't know what else to recommend, but I feel like there must be something better. If not, there's some low-hanging fruit for a quality engineer with a decent command of the English language.