Warning Letter noting failure to test all software requirements for a medical device.
This Warning Letter includes an observation regarding failure to conduct a complete design verification of the software requirements of a multimode electrical stimulator. Verification testing did not include all software requirements. For example, verification testing did not include the control/reset of the treatment timer, idle shut off functionality, and the treatment data storage functionality.
|pa document category||Warning Letter|
|Regulation Category||Devices – GMP|
|FDA Office||Denver District|
|System Category||Medical Device|