![“Design Controls for the Medical Device Industry, Third Edition (English Edition)”，作者：[Marie B. Teixeira]](https://images-cn.ssl-images-amazon.cn/images/I/41V3tq2Aq-L._SY346_.jpg)
I will preface this review by stating that this is the first book on this particular subject that I've ever purchased. I'm a hardware and software engineer by training, so I was looking for a concise reference on what all is required by the FDA during product development, and how to maintain a design history file. Well, ok, I guess that information is in the book, but an awful lot of the material is either obvious, or repeated multiple times. Then there are gems like this sentence:
"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.
此商品在美国亚马逊上最有用的商品评论
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2 条评论
MyDirtIsRed
Repetitive, could be much more concise
2020年6月6日 -
已在美国亚马逊上发表已确认购买
Jenn
Great reference book!
2019年12月10日 -
已在美国亚马逊上发表
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