Software Validation Documentation for Medical Devices - FDA eSTAR
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YouTubeMedical Device Academy
Software Validation Documentation for Medical Devices - FDA eSTAR
This video shows you how to use SYS-044, our software validation procedure and associated templates to document your software validation for a medical device (i.e., SaMD, SiMD, or Firmware). The video also shows you where to attach these documents in the new FDA eSTAR v5.1 for 510(k) and De Novo submissions. The video includes novel diagrams ...
3.6K viewsMar 7, 2024
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