If your device does not contain software, this whole section can be omitted.
Description of the device and SW
The device and SW is defined in the System design description DocId XXXXX.>
Statement of compliance with IEC/EN 62304
The software will be developed in accordance with the requirements of IEC/EN 62304. (1)
(1) You may want to add which version of the standard, the current one is IEC 62304:2006, soon to be amended.
Reference to SW development aspects relating to RM
List the activities that you have in your SW development plan (which is mandatory for all medical device SW development).
The following activities within SW development is relating to RM:
Risk acceptance criteria for SW
This section is here to make it easier to audit. It is actually covered in the criteria for risk acceptability section.