Ebook Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation
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Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation
Ebook Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation
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Product details
Paperback: 442 pages
Publisher: Design Controls, Risk Management and Process Validation for Medical Device Professionals; 1 edition (February 11, 2017)
Language: English
ISBN-10: 0692835415
ISBN-13: 978-0692835418
Product Dimensions:
8.5 x 1 x 11 inches
Shipping Weight: 2.4 pounds (View shipping rates and policies)
Average Customer Review:
4.1 out of 5 stars
4 customer reviews
Amazon Best Sellers Rank:
#1,168,036 in Books (See Top 100 in Books)
The book is well organized and aligns directly with the FDA design control requirements. It provides a step-by-step approach of how to set up a quality system. This book was exactly what I needed to read at this phase of our startup company. It reinforced everything I have already learned working at larger medical device companies. The section that gave real-world examples of how to combine electrical, software, and mechanical requirements together was particularly useful.
I bought this book specifically for the Process Validation information and was very disappointed. The book is largely a regurgitation of FDA regs, mostly CFR820. The one chapter on process validation was verbatim from the GHTF report on validation. There were very few real world examples or applications advise which is what I was looking for. The best practices were lame like :="FDA expects a pre-approved protocol before verification is executed." - Really? This should be labeled as Captain Obvious. For a book costing ~$130 I expected a lot more.
This is a great reference book for medical device professionals. I'm usually looking online for FDA guidance documents to assist me in decision making, this book has a great compilation of guidance documents for your reference. In addition, the author does a good job in providing methodical guidance in the areas of risk mangament and design development. The information is coherent and well organized. Overall, a very good book for those starting in the medical device field and for those experienced but requiring a quick method of reference.
Thorough, relevant, and real-world resource for the medical device professional. After 20 years’ experience in both large and small medical device companies I have seen a variety of successful approaches to Design Controls, Risk Management and Process Validation. I now have a comprehensive book that clearly lays out FDA & ISO requirements while combining them with practical case studies. I believe this book would be great for experienced engineers and for those just starting out in the industry.
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