It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent. Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development, medical device companies also need to be looking for new and improved ways to validate that software.
In this audio conference we examine the various approaches to software validation, and discuss how and why to consider risk as part of the validation process. The presentation also looks at ANSI/AAMI/IEC 62304:2006 Medical Device Software - Software Lifecycle Processes, and how it uses risk to drive software verification and validation.
Risk-Based Software Validation for Medical Devices is being presented by Bob Barrett, Systems Engineering Lead, with Intertech Engineering Associates, Inc. and airs on Wednesday, April 22nd, 2009. To register, or for more details please visit our site www.fxconferences.com
