Software Validation Form
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Use this Software Validation Form template to systematically document the validation process for software used in quality management or production of medical devices, ensuring compliance with regulatory requirements. Complete this form whenever you implement, update, or assess software that could impact device quality, performance, or regulatory compliance, as it guides you through risk assessment, validation planning, testing, and ongoing monitoring. This template is essential for demonstrating that your software is fit for its intended use and that risks are effectively managed and controlled.