Improving Verification & Validation in the Medical Device Domain

Abstract

The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical de- vice domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The pa- per is intended to highlight three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Addition- ally, we also performed a review of the standards and process improvement models available in these domains.