Customer Review

8 of 8 people found the following review helpful
5.0 out of 5 stars Practical, Insightful and Readable, January 10, 2011
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.
Help other customers find the most helpful reviews 
Was this review helpful to you? Yes No

Be the first person to comment on this review.

[Add comment]
Post a comment
To insert a product link use the format: [[ASIN:ASIN product-title]] (What's this?)
Amazon will display this name with all your submissions, including reviews and discussion posts. (Learn more)
Name:
Badge:
This badge will be assigned to you and will appear along with your name.
There was an error. Please try again.
Please see the full guidelines here.

Official Comment

As a representative of this product you can post one Official Comment on this review. It will appear immediately below the review wherever it is displayed.   Learn more
The following name and badge will be shown with this comment:
 (edit name)
After clicking the Post button you will be asked to create your public name, which will be shown with all your contributions.

Is this your product?

If you are the author, artist, manufacturer or an official representative of this product, you can post an Official Comment on this review. It will appear immediately below the review wherever it is displayed.  Learn more
Otherwise, you can still post a regular comment on this review.

Is this your product?

If you are the author, artist, manufacturer or an official representative of this product, you can post an Official Comment on this review. It will appear immediately below the review wherever it is displayed.   Learn more
 
System timed out

We were unable to verify whether you represent the product. Please try again later, or retry now. Otherwise you can post a regular comment.

Since you previously posted an Official Comment, this comment will appear in the comment section below. You also have the option to edit your Official Comment.   Learn more
The maximum number of Official Comments have been posted. This comment will appear in the comment section below.   Learn more
Prompts for sign-in
 


Review Details

Item

4.2 out of 5 stars (5 customer reviews)
5 star:
 (4)
4 star:    (0)
3 star:    (0)
2 star:    (0)
1 star:
 (1)
 
 
 
$139.00 $123.91
Add to cart Add to wishlist
Reviewer


Location: Plainville, MA USA

Top Reviewer Ranking: 16,627,758