This document is the collection of records that provide evidence of the validation activities of the Software as Medical Device (SaMD) or integrated within the device. The documents included are:
– Software Validation
– System Design and Development Plan
– Software Requirements
– Software Design Specifications
– Verification and Validation
– Software Risk Analysis
– Traceability Analysis
– Revision History
– Unresolved Faults
– Report EN 62304″

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