TMS320F28035: IQMath verification documentation

we would like to you what certification you intend to do ? if you can provide us the details we can help you with our suggestions. 

Thanks

Aravindhan

Hello,
We are aiming at an ISO 62304 certification (software for medical devices). In this context we consider the IQMath as a SOUP. Hence we need documentation to show that it has been developed and tested according to certain controlled processes.
regards,
Didier

Didier,

Sorry for the delay in getting back to you. I will inquire internally about this and get back to you in a day or so. At the outset, I do want to mention that, in general, our libraries are provided as-is to users without any quality guarantees. Also, if you look into the License.txt file that accompanies the C2000Ware release in which the IQMath library resides, you will see the following note:

"5. High Risk Products. The Licensed Materials are not fault tolerant and are not designed, manufactured or intended for incorporation into products where the failure of such products could lead directly to death, personal injury, or severe physical or environmental damage ("High Risk Products"). You shall notify your customers that neither the TI Devices nor the Licensed Materials are intended for use in High Risk Products. Further, you shall instruct direct customers to pass this information with the Licensed Materials through distribution channels. You acknowledge and agree that you are responsible for the safety of your products and for ensuring that your systems and products meet all applicable state, national and international safety, regulatory and system-level performance requirements as well as other applicable requirements. You represent and agree that you have all the necessary expertise to create and implement safeguards which anticipate dangerous consequences of failures, monitor failures and their consequences, lessen the likelihood of failures that might cause harm and take appropriate remedial actions. You will fully indemnify TI and its representatives against any damages arising out of the use of the Licensed Materials in such products."

As far as development processes and the availability of test reports - this is something that a lot of effort is being put into in the recent past, so we have requirements, tasks, and bugs filed in JIRA, and test reports created out of validation efforts on software prior to release.

Please let me know if you have any questions or comments.

Thanks,
Sira

Didier,

I just reviewed ISO 62304 a bit, and it seems to have 3 classes. Which class would your application fall under? Also, do you consider your application a "High risk product" (as stated in our license)?

Thanks,
Sira

Hello Sira,

I would consider our product a "high risk product". Our software falls into class C of IEC 62304. 

Any evidence you could provide us of testing and and test results will help us, but we will conduct our own testing.

Regards,

Didier