Medical Device Software Verification, V

A healthy dose of perspective on every page. David Vogel's book is a gem for those new to the field. I've been working in this arena for only five years, and I have found the book to be extremely helpful. I keep catching myself thinking, "Wish I'd known this four years ago!"

Book arrived promptly and was in great condition but it did not contain the DVD advertised. Disappointing as this is a reference book and the DVD contains additional references of interest.

Strong overview of the subject. Did not include DVD with templates

Though the content of the book is useful, but the figures are not clear and it is blurred. Disappointed with this PC Kindle version.

This book is one of my favorite books on software validation and verification! I highly recommend it. I reread it once or twice a year and-- each time I do that, I pick up something new and interesting!

It have all the guidance I was looking for to do my job. The author knows his business. Will read more.

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.

Missing DVD!