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I have several technical questions relating to the TMS570LC4357 MCU. We are developing a Class 3 medical device and are investigating use of this chip in our product.
"No TI components are authorized for use in FDA Class III (or similar life-critical medical equipment) unless authorized officers of the parties have executed a special agreement specifically governing such use"
Does this clause apply to the TMS570LC4357 chip, and if so what is the procedure to execute such an agreement?
What is the supported life of the TMS570LC4357, are there any plans for NRND or obsolescence of this chip?
The TMS570 devices have been in the market for several years, and Cortex-R4/R5 are very mature architecture with SoC integration features for use in deeply embedded real-time and safety-critical systems. We don't have plan to EOL any of TMS570 parts.
TI policies for standard product longevity
TI standard products are not eligible for obsolescence if any of these three conditions exist:
https://www.ti.com/support-quality/quality-policies-procedures/product-life-cycle.html
Does this clause apply to the TMS570LC4357 chip, and if so what is the procedure to execute such an agreement?
Yes, I think this clause (FSA Class 3 device) also applies to Hercules devices.
The Hercules MCUs are not developed compliant to the IEC 60601 series of standards for medical devices. These products target the IEC 61508 and ISO 26262 standards, which introduce functional safety requirements at the component level for compliant hardware. Because IEC 61508 and IEC 60601 have many core concepts in common, use of an IEC 61508 compliant component may help reduce development effort for IEC 60601 system developers.
Can you please share TI's MISRA compliance policy document for HalCoGen and safety software products (as mentioned here)
I don't have this policy document.
After checking with team members, we don't have the policy document mentioned in your query.
Hi Hugo,
My apologies for my delayed response, I haven't found the procedure to execute the agreement of using TMS570 in FDA Class III medical devices.
Hi Hugo,
If a customer wants to use one of our products in a FDA Class 3 medical device (life critical), the TI legal needs to have some involvement and awareness of our engagement.
You can evaluate the TMS570LC4357 and its functional safety package (SDL, HalCoGen, CSP, etc) on TMS570LC43x launchpad.
https://www.ti.com/tool/LAUNCHXL2-570LC43
Once you decide to use TMS570 MCU for your product, our marketing team will initiate the process with our legal team.
Excellent, thank you for the update QJ. Can you provide a contact for the marketing or legal team please?
Hi Hugo,
I have make a friend request, so you can send me your email addr there.