Managing Risk in Medical Software: A Quality Assurance Framework for Healthcare Technology

Abstract

The integration of technology in healthcare has revolutionized patient care and operational efficiency, but it also introduces significant risks associated with medical software. Effective risk management is essential in the quality assurance (QA) process for these systems, given the potential implications for patient safety and data security. This paper explores the critical importance of risk management in medical software, presenting a structured framework for identifying, assessing, and mitigating risks throughout the software development lifecycle (SDLC). The framework incorporates advanced testing techniques, adherence to regulatory standards, and continuous monitoring to enhance the safety, security, and reliability of medical software systems. It underscores the necessity of robust risk management strategies that protect patient data, ensure system functionality, and facilitate high-quality care delivery. By establishing clear protocols for risk assessment and management, healthcare organizations can foster stakeholder confidence and improve overall healthcare outcomes. Ultimately, this manuscript aims to equip healthcare technology developers and quality assurance professionals with the knowledge needed to navigate the complexities of medical software while prioritizing patient safety and regulatory compliance.