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(More customer reviews)First, a disclaimer. I've worked for Dave Vogel for the past 23 years. I was hired during my University Co-Op Education days and have been with Intertech Engineering (the company Dave Vogel founded in 1982) ever since. There is a reason I've stayed - Intertech gets it right. And, fortunately, so does this book.
If I were asked to name reading material that would be a sure-fire cure for insomnia, you can bet the FDA's Regulation and Guidance documents (21 CFR 820 and GPSV) would be high on the list. Those regulations and guidance documents are frequently mired in difficult to understand language and, occasionally, contradictory suggestions. For years we struggled as a company to institute a quality process that is both compliant and practical (this later desire is actually the harder of the two). Over the years we've seen the highs and lows when it comes to Verification & Validation of Medical Device Software and we've learned more than a few things along the way. Much of what we've learned has been laid out beautifully in this book. Very little of the technical content surprised me here - we've been living and using this stuff for many years now. What did surprise me was the approachable and highly readable style of the book. Pulling in relevant sections of the Regulatory code and guidance along with advice and examples, the book lays out not only the "hows" but the "whys" when it comes to Verification & Validation. The no-nonsense approach should be a perfect fit for people who want a hands-on approach to thinking through their quality systems and has plenty of advice to guard against over-engineering the process (or worse, taking shortcuts to avoid the hard decisions). The book doesn't bog down in technical detail nor does it float along in abstract theory which makes it practical for the vast majority of readers. Dave is neither pretentious nor preachy in his writing style and I've found the book to be a welcome companion here in the workplace. If you're feeling lost, confused or frightened when it comes to Verification & Validation of Medical Device Software (and you're certainly not alone), I'd highly recommend you give this a read-through. I suspect you'll find it to be a valuable addition to your professional library.
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Here s the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software s safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer s quality system and is regulated by 21 CFR 820.70(i).DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book.
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