Seeking Tool Qualification / Compliance Evidence for ModelSim Intel Starter Edition 10.5b

Hi,

We are currently developing a medical device and must comply with IEC 62304 standards. We use ModelSim - INTEL FPGA STARTER EDITION 10.5b (Revision: 2016.10) for our FPGA logic verification.

Our auditor requires "Tool Validation" or "Tool Qualification" evidence to prove the simulator's reliability. Since we are constrained by our current hardware environment, we cannot upgrade the toolchain at this stage.

Does Altera/Intel provide a Functional Safety Data Package or any TÜV certificates (for ISO 26262 / IEC 61508) that covers the 10.5b engine?

Is there an official "Quality Statement" or "Certificate of Compliance" for this legacy version?

Any official documentation would be extremely helpful for our audit.

Thank you for your support.