CCS/TI-RTOS-MCU: Use of TI RTOS in Class 3 medical device

Randhir Kalsi

Part Number: TI-RTOS-MCU
Other Parts Discussed in Thread: CC2642R, CC2642R-Q1

Tool/software: Code Composer Studio

Hello team,

Hope you are doing. When you get a chance would you mind commenting on below?

If we decide to use the ti rtos or the ti drivers in a class 3 medical device the FDA will require testing and documentation for the software. Does TI have any certification documentation packages available? Or the source code for the rtos and drivers?

over 3 years ago

0 JohnS over 3 years ago

TI__Guru**** 159725 points

Randhir,

Can you me know which device is being used so that I can direct this to the appropriate team.

Regards,

John

0 Randhir Kalsi over 3 years ago in reply to JohnS

TI__Expert 4545 points

John,

CC2642R

0 JohnS over 3 years ago in reply to Randhir Kalsi

TI__Guru**** 159725 points

Thanks Randhir.

0 Luis M over 3 years ago in reply to JohnS

TI__Expert 5345 points

Randhir,

An expert in certification will help you shortly.

-Luis

0 Clément over 3 years ago in reply to Luis M

TI__Guru* 94158 points

Hi Randhir,

I think you should look into our CC2642R-Q1 device.

For the rest,I need to do some additional researches in order to give you a good answer. It would help if you could you specify which certifications interest you?

Kind regards,

0 Clément over 3 years ago in reply to Clément

TI__Guru* 94158 points

Hi Randhir,

Class 3 medical devices are considered Life-Critical systems, and TI’s terms of sale come with very specific instructions.

Bottom line TI needs to authorize of the customer use case before the customer can use the device and associated software in a Life-Critical product.

Best regards,

0 Randhir Kalsi over 3 years ago in reply to Clément

TI__Expert 4545 points

Thank you for the response Clément.

We are working with the customer to sign an A&I agreement but customer is asking for clarification prior to signing the document.

Does TI have any certification documentation or the source code for the rtos and drivers as FDA will require testing and documentation for the SW.

0 Clément over 3 years ago in reply to Randhir Kalsi

TI__Guru* 94158 points

Hi,

Thank you for your patience. I asked our Quality team. What we have will not support Class III medical devices.

To qualify their system for Class III medical devices, they would need to work new solutions and go through the qualification process on their own, using our drivers/RTOS as example software.

Best regards,

Code Composer Studio™︎

Code Composer Studio forum

CCS/TI-RTOS-MCU: Use of TI RTOS in Class 3 medical device