Validation and Verification of Medical Device Software: Approaches, Methodologies, and Case Studies

Abstract

Validation and verification (V&V) of medical device software are critical processes aimed at ensuring the safety, efficacy, and regulatory compliance of software-based medical devices. This abstract presents a comprehensive review of approaches, methodologies, and case studies related to V&V in medical device software development. The paper explores various V&V techniques, including requirements validation, software testing, and software validation, tailored to the unique challenges of the medical device industry. It discusses best practices for establishing V&V processes, including the use of standardized frameworks such as IEC 62304 and FDA guidelines. Additionally, the abstract presents case studies highlighting real-world examples of successful V&V implementations in medical device software development. By examining different approaches and methodologies, this paper aims to provide insights into effective V&V practices and facilitate the development of safe, reliable, and compliant medical device software solutions.