Medical Device Software Safety, Validation, Verification, and Effectiveness

• Activity Number: 566
• Type: Topic Contributed
• Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Carolyn Carroll*+
• Companies: STAT TECH, Inc.
• Keywords: devices ; software ; validation

Abstract

Software either in medical devices or used to design, manufacture or test devices must be verified and validated. The process of specifying, designing, developing, testing, verifying and validating software are inter-related processes. A bad job of requirements specification leads to problems in the entire development cycle and makes thorough testing difficult if not impossible.

Validation techniques commonly employed in software development environments involve static methods such as design reviews and inspections and dynamic techniques such as scenario based testing. Unfortunately, these methods rely on clear and correct requirements specification and good software development techniques. They are also difficult and time consuming to implement. When newer devices with adaptive functioning are implemented validation will become still more complicated.