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Risk management plan – Software risk management

If your device does not contain software, this whole section can be omitted.

Description of the device and SW

Example text:

The device and SW is defined in the System design description DocId XXXXX.>

Statement of compliance with IEC/EN 62304

Example text:

The software will be developed in accordance with the requirements of IEC/EN 62304. (1)

Comments:

(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).

Example text:

The following activities within SW development is relating to RM:
<TBD>

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.

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