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MOTORWARE: instaSPIN MOTION in medical application - FDA documentation

Mariano
Intellectual 370 points
Part Number: MOTORWARE
Other Parts Discussed in Thread: LAUNCHXL-F28069M, BOOSTXL-DRV8301

hi, we need to control a bldc motor using instaSpin motion for accuracy speed control, the product is a medical device and FDA certification is a must, is any documentation or recommendation about this topic ?

we are evaluating launchxl-F28069M + boostxl-drv8301  .

thanks

  • 0
    TI__Guru** 119670 points
    Sorry, we don't have any documentation on this topic. If you need archival source code of libraries used that won't be possible with InstaSPIN. The FAST and SpinTAC libraries are always kept private, we do not release.

    There are other medical applications however that don't require full source code, I suppose it depends on how important the product is to sustaining life?
  • 0 in reply to ChrisClearman
    Intellectual 370 points
    thanks Chris, our device is Class II, i´m not sure what kind of evidence we need about FAST and SpintTac, maybe unit test evidence; but SpinTac in F28069M uC runs on chip not as a library, so i don`t know what kind of evidence FDA is needed.
    any suggestion is welcome.
  • 0 in reply to Mariano
    TI__Guru** 119670 points
    SpinTAC has some portions in user code, but the key algorithm is in the on-chip library in ROM.

    You will need to find out the requirements for your software from the standards body or auditing agency. We can't tell you what is required.