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Software System Test Plan

Use this Software System Test Plan template to systematically verify that your medical device software meets all defined requirements before release. This document is essential for planning and documenting comprehensive system-level testing, ensuring regulatory compliance, and should be completed during the final stages of software development prior to generating the system test report. Filling out this template helps you identify and address any test failures, supporting a robust validation process for FDA and EU MDR submissions.

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Software System Test Plan

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1. Scope

The software system test plan provides verification of the software requirements and should be performed according to the Software Development and Maintenance plan. The software system test report will be created following the execution of the software system test plan. Any software tests that do not perform correctly need to be addressed or justified prior to software release.

2. Test Plan

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