IMPROVING THE EFFECTIVENESS OF MEDICAL DEVICE SOFTWARE VALIDATION

Abstract

Keywords: Testing, test coverage, return on investment

Testing requires a significant investment in time and effort. The return on this investment is measured in terms of information gained compared to effort required. Most companies have no effective way to assess effectiveness of testing they do, and thus cannot measure return on investment.

As test suites evolve over time, they often include hundreds of "non-productive" tests. These tests look for problems in areas where there aren't problems. More importantly, there may be areas of the product that have inadequate or non-existent test coverage.

Learning how to measure and increase testing effectiveness means that critical information can be identified sooner and a higher return on investment can be achieved.

Bios

Steven R. Rakitin has over 30 years experience as a software engineer and software quality manager. He has written several papers on the subject of software quality and published a book titled: Software Verification & Validation for Practitioners and Managers. He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He has earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a member of the IEEE Computer Society, ASQ Software Division, ASQ Biomedical Division, Association for the Advancement of Medical Instrumentation (AAMI), and is on the Editorial Review Board for the ASQ Journal Software Quality Professional. As President of Software Quality Consulting Inc., he helps medical device companies comply with regulations in a more efficient and cost-effective manner.