8 of 8 people found the following review helpful
Practical, Insightful and Readable,
This review is from: Medical Device Software Verification, Validation and Compliance (Hardcover)
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.