This article explores the process of software engineering methodology and its significance in the development of medical devices. It reviews a case study on software risk analysis and planning in medical device development, examining the research methods, data collection, and analysis techniques used in the study. The authors highlight the importance of risk management in software development and identify the risks and issues related to software development and medical devices. They argue that risk management is a major section of the software development process that provides a way for controlling and handling the security of the developed systems. The article is relevant to the software engineering methodology and can help students understand the implication of software engineering techniques in the business communities.
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