Medical Device Software:

Verification, Validation, and Compliance

By David A. Vogel
Artech House (2011)

Faulty software can mean more than just a crashed computer — in the medical community “working technology” can spell the difference between life and death. Computer software is becoming more and more integral to medicine, and an essential component of patient care, from as simple X-ray to a life-saving heart transplant.

Regulation and quality assurance are thus necessities in this industry, though effective implementation is all too often hindered by unclear expectations and competing interests. Since the 1970s, when the microcomputer became a force to be reckoned with, the FDA has worked hard to implement regulation and oversight of medical devices. But the process is still fraught with delay, error, cost and sometimes danger.

In his new book, Medical Device Software: Verification, Validation, and Compliance, just published by Artech House, Dave Vogel tackles this tough and tricky subject. The first book of its kind, Medical Device Software, is geared specifically for medical device and software engineers, for quality assurance and compliance professionals, and for corporate business managers—the very folks who interact and do battle with these issues every day.

To help them, Dave offers an in-depth yet very readable examination of medical device software validation, carefully outlining all relevant topics required for looking critically at these issues. In specific, Medical Device Software details validation activities for each phase of development, explains why these activities are important, shows how to undertake them, and, as well, describes methods for proper documentation. The book even includes a DVD, offering a collection of FDA regulations and guidance documents, and sample forms and supplemental information.

A cutting edge thoughtleader who has published many articles in medical device industry journals, Dave Vogel founded Intertech Engineering Associates in 1982 as one of the first consulting firms to offer outsourced engineering services for medical device manufacturers. The methods described in Medical Device Software are derived from the almost 30 years of experience Intertech has spent developing and validating its clients’ medical devices.  Today, Intertech’s product verification and validation service for software-based instrumentation boasts a 100% safety record!

Because of this track record, Medical Device Software can offer a practical and one-of-a-kind resource for every professional in the field of medical software verification, a resource that readers can turn to again and again. Though there may never be a one-size-fits-all approach to such a complex subject, Dave’s book offers interpretations and explanations for any situation, assuring that life-saving standards and regulations are always met. The Association for the Advancement of Medical Instrumentation agrees, and has contracted with Dave to develop a three-day course based on his book. For details, visit the training section of the AAMI website.

To find out where to order of copy of Medical Device Software: Verification, Validation, and Compliance, click here.

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