SOP Software Development
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Use this SOP Software Development template to establish a compliant, structured process for developing medical device software in line with IEC 62304 and IEC 62366 requirements. This document is essential for ensuring software safety, performance, risk management, and usability, and should be completed and maintained for each new software project or when significant changes are made. Fill out this template to guide your team through all required software development lifecycle stages, support regulatory submissions, and maintain robust technical documentation for audits and product approvals.