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″
Available Languages: English
The information contained on this page and in the documents referred to is valid and current as of 07/17/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. Disclaimer
