SoftDevice for IEC 61508-SIL 3?

[Sebastien Bourdelin]

Hi here,

I m working with a medical device which should probably have to be certified IEC 61508-SIL 3.

I m still new with that certification process, and wondering if your SoftDevices have some pre-certifications as it will probably drives our approach to the product.

Thanks,

Sebastien. 

[Kenneth]

I am not aware of any, but let me check a bit internally if we have anything related.

Kenneth

[Sebastien Bourdelin]

Thank you Kenneth!

[Kenneth]

For the medical certification - SD does not have any certifications. It has been used as SOUP(SW Of Unknown Provence) within the cerification process by customers. I am trying to get more information about what this means.

Kenneth

[Sebastien Bourdelin]

Ok, that's still very interesting for us to know how your other customers had deal with their certification process, so thanks a lot for that!

We will probably ask expertise to a third party to guide us with that certification process, so i keep that SOUP term in mind