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 showing when various documents are created in the software development process.
Links:
SYS-044 - [ Ссылка ]
WI-007 - [ Ссылка ]
What is IEC 62304? - [ Ссылка ]
What is IEC TR 80002-1:2009 - [ Ссылка ]
