SOP Software Problem Resolution
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Use this SOP Software Problem Resolution template to systematically document, investigate, and resolve software issues for your medical device products, both before and after market release. Filling out this template is essential whenever a software problem is identified—whether during development, from user feedback, or post-market surveillance—to ensure compliance with ISO 62304 requirements and maintain device safety, performance, and regulatory traceability. This process helps you track problem reports, conduct root cause analysis, implement corrective actions, and update risk management files as needed.