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Validation of Software

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My company produces medical devices and are required by the FDA to validate our software.  One of our products uses a battery that is evaluated and calibrated by the bq2060AEVM-001 and bq2060AEVM-002 SBS 1.1 Battery Management Solution Evaluation Module.  There is nothing on the TI website that I could find and customer support was unable to help.

My question is becomes is there a pre-existing validation of this software? Or is there a good way to do a validation of this software myself?

I need something to essentially prove that the EV2200-60 program does what it says it will do.

Thank you for any help in resolving this. 


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