We are developing a medical device class II and regulated by IEC62304.
This means a notifying body will and shall have insights in our developments methods.
Also they will see some proof regarding the used development environments etc.
We are using the (per-certified) S7G2 chip, ThreadX and Xware components to accomplish this. So far so good!
We are now looking for the per-certified documentation for all this that we will need for proving we meet the IEC 62304 regulations. Any one know were to find these ?
Hello eefje. I don't think the requested information is available publicly. You can reach out to the Renesas team to get more help in this matter by raising a ticket from here: https://en-support.renesas.com/dashboardThank you,JayeshIf this response, or one provided by another user, answers your question, please verify the answer. Thank you!Renesas Engineering Community Moderatorshttps://community.renesas.com/https://academy.renesas.com/en-support.renesas.com/.../
I will do that.