Jetson TX2 used as a medical device


I am working in healthcare and we are manufacturing medical devices in Europe.

We are using Jetson TX2 as part of one of our medical devices. However, the ISO 13485 standard requires that “Purchasing information shall include, as applicable, a written agreement that the supplier notifies the organization of changes in the purchased product prior to the implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements.”

So, I would like to know what information can NVIDIA provide me to help with this (FCC certification is not enough apparently) or who I should contact to know more relating this at NVIDIA.

Thank you very much in advance.

Hi alexandremg0jh,

Is the JEDEC JESD-046 compliance met your requirement? Currently it’s not published, also not included in any doc yet. We’re discussing internally to get a proper place to provide relevant information. Please stay tuned.

Hi alexandremg0jh,

We have published some PCNs on the Jetson Download Center as your reference: