Thursday, April 8, 2010

Medical Device Software Safety, Validation, Verification and Effectiveness. Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM

Carolyn Carroll of Stat Tech Inc. will be presenting Medical Device Software Safety, Validation, Verification and Effectiveness on Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM, at the 2010 Joint Statistical Meeting. Held July 31-August 5, 2010, at the Vancouver Convention Centre, located at 1055 Canada Place, Vancouver, BC, V6C 0C3, Canada.

"JSM (the Joint Statistical Meetings) is the largest gathering of statisticians held in North America. It is held jointly with the American Statistical Association, the International Biometric Society (ENAR and WNAR), the Institute of Mathematical Statistics, the Statistical Society of Canada, and the International Chinese Statistical Association, and the International Indian Statistical Association."


"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."