Reliable Design of Medical Devices (Third Edition)

产品(数学) 过程(计算) 计算机科学 新产品开发 点(几何) 知识产权 工程管理 工程类 业务 几何学 数学 操作系统 营销
作者
Pat Baird
出处
期刊:Biomedical Instrumentation & Technology [Association for the Advancement of Medical Instrumentation]
卷期号:47 (5): 439-439
标识
DOI:10.2345/0899-8205-47.5.439
摘要

If you develop medical devices, you will like Reliable Design of Medical Devices (Third Edition). Don't let the name fool you—this book is about much more than reliability engineering. While this book opens with a discussion of reliability and failure, it quickly transitions to discussing the entire product development process, from concept through verification, and even includes design transfer and post-market field actions.The book also covers related topics, such as risk management, regulations from the U.S. Food and Drug Administration, and the Medical Device Directive. These chapters are particularly useful for developers who already know product design processes, but do not know the regulatory requirements placed on medical devices.Audience: This book is suitable for product development teams. Multiple disciplines are covered: mechanical, electrical, software, human factors, and reliability. In addition, it covers requirements management and even project management.Assessment: There is a lot of wisdom in this book. You can tell that the author has seen a lot of projects and wants the reader to avoid the mistakes that he has encountered. An example can be found in Chapter 3, regarding planning. In this discussion, every phase of the process ends with a bullet point of “document everything.” Rather than simply saying “document everything” once in the narrative, the author reinforces this point at every step.This book also covers topics that are typically not addressed, such as product liability and protecting intellectual property, and it includes discussions about the importance of a good team in project success.Reliable Design of Medical Devices isn't the type of book that you sit down with and read cover to cover. Rather, it is best used as a reference for those new to medical device product development, as well as for a team grappling with a particular issue. Each chapter has a bibliography for additional reading.In terms of easily finding the advice and information you need, the index will prove to be helpful because the chapter titles don't always indicate all that is included within a particular chapter. For example, the discussion about regulatory requirements is found in the chapter on feasibility. To be clear, I'm not faulting the book—there is a lot of information to convey, and there is no single best way to organize that information. Just know that in the few months I've been using the book, I found it most useful to use the index to direct me, rather than flip through the pages hunting for a particular topic.There are some improvements that I would like to see in the next revision to make the book even more useful. For example, the human factors section is mostly about ergonomics, and there is no mention of the existing body of knowledge that has been captured in IEC 62366 and HE 75, and there are no pointers to professional societies such as the Human Factors and Ergonomics Society. Chapter 18 is a repeat of Chapter 5, almost word for word. Unfortunately, the topic of change control is missing from the book.Assessment: This book is like having a product development consultant on your bookshelf, sharing his experience on what does and does not work. The breadth of knowledge is considerable: the table of contents alone is 19 pages long. This book is a good starting point for a wide variety of topics, and if you treat it like a reference book, it will serve you well.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
道阻且长发布了新的文献求助10
1秒前
heartsooo完成签到,获得积分10
1秒前
2秒前
Talk完成签到,获得积分10
2秒前
3秒前
废寝忘食发布了新的文献求助20
3秒前
3秒前
3秒前
chen0815发布了新的文献求助10
6秒前
6秒前
听说发布了新的文献求助10
7秒前
cranberry完成签到,获得积分10
7秒前
科研12345完成签到 ,获得积分10
7秒前
7秒前
筏A完成签到,获得积分20
8秒前
Reftro发布了新的文献求助10
8秒前
Zwj发布了新的文献求助10
8秒前
9秒前
灵巧荆发布了新的文献求助10
9秒前
蘅江完成签到,获得积分10
9秒前
热心蛋挞完成签到,获得积分10
9秒前
10秒前
野原完成签到,获得积分20
12秒前
13秒前
LZR完成签到,获得积分10
14秒前
chen0815完成签到,获得积分20
16秒前
大模型应助Zwj采纳,获得10
16秒前
16秒前
安陌煜发布了新的文献求助10
16秒前
卜卜脆完成签到,获得积分10
16秒前
听说完成签到,获得积分10
17秒前
神勇乘云发布了新的文献求助30
18秒前
wanci应助野原采纳,获得10
18秒前
方沅发布了新的文献求助10
20秒前
ding应助再睡十分钟采纳,获得10
21秒前
ll完成签到,获得积分10
21秒前
21秒前
华仔应助niuhulushi采纳,获得10
21秒前
不安的从霜完成签到,获得积分10
21秒前
高分求助中
The late Devonian Standard Conodont Zonation 2000
Nickel superalloy market size, share, growth, trends, and forecast 2023-2030 2000
The Lali Section: An Excellent Reference Section for Upper - Devonian in South China 1500
Smart but Scattered: The Revolutionary Executive Skills Approach to Helping Kids Reach Their Potential (第二版) 1000
Very-high-order BVD Schemes Using β-variable THINC Method 830
Mantiden: Faszinierende Lauerjäger Faszinierende Lauerjäger 800
PraxisRatgeber: Mantiden: Faszinierende Lauerjäger 800
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3247880
求助须知:如何正确求助?哪些是违规求助? 2891121
关于积分的说明 8266211
捐赠科研通 2559325
什么是DOI,文献DOI怎么找? 1388116
科研通“疑难数据库(出版商)”最低求助积分说明 650698
邀请新用户注册赠送积分活动 627581