How to obtain the pre-certified documentation for IEC62304 certification


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 ?

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