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.

This audio conference examines the various approaches to software validation, and discusses 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.

This audio conference covers:

• Why risk is an effective tool to guide resource assignments
• How IEC 62304 presents risk-based process approaches that can benefit a process
• Why all software development and validation is not the same
• A brief introduction to risk analysis methods
• Why there is no silver bullet in any one particular approach

About the speaker:

Bob Barrett is Systems Engineering Lead with Intertech Engineering Associates, Inc. and has 20 years of experience in project and engineering leadership, focusing on teamwork and results. His areas of expertise include risk analysis, software embedded medical device design, systems engineering, design validation and verification, requirements development, quality management and project management.

Before joining Intertech, Bob spent 18 years with Baxter Healthcare. In his most recent role as Director of Systems Engineering he was responsible for the creation of the Systems Engineering Department, led complex programs and projects, released multiple medical products and developed a multifaceted Systems Engineering organization that specialized in system architecture, verification and validation, and risk management of new and existing products.

Prior to that, as Quality and Reliability Manager, he was responsible for design quality engineering, manufacturing and service quality supporting multiple lines of Class II products. Bob has an Engineering Undergraduate Degree and an MBA with a project management focus.

Who should attend?

• Engineering/R&D
• Software Developers
• Software Testers
• Project Managers
• Software Quality Assurance
• Regulatory Affairs
• Resource Managers

* Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.