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Classes | IEC 62304:2006 Section | Document Section |
---|---|---|
A, B, C | 6.2.3 | 2 |
A, B, C | 6.2.4 | 2 |
A, B, C | 6.2.5 | 2 |
A, B, C | 6.3.1 | 3 |
A, B, C | 6.3.2 | 3 |
A, B, C | 7.4.1 | 2 |
B, C | 7.4.2 | 2 |
B, C | 7.4.3 | 2 |
A, B, C | 8.2.1 | 2 |
A, B, C | 8.2.2 | 3 |
A, B, C | 8.2.3 | 3 |
A, B, C | 8.2.4 | 3 |
A, B, C | 9.4 | (All) |
This SOP describes how we evaluate and make changes to our software after it’s released.
Changes proposals can originate from various sources, e.g.:
They can originate from anywhere inside the company.
A change request is created with a description of the proposed change.
Participants |
---|
Anyone in the company with a change proposal |
Input | Output |
---|---|
Change proposal | Change request |
The proposed change is evaluated. Most importantly, it is evaluated whether the change:
The evaluation results in a decision whether the change is implemented and whether the notified body needs to be involved if the change is substantial. These two decisions are documented in the change request.
Multiple proposed changes can be batched and discussed in one session.
Participants |
---|
Head of Software Development |
Product Manager |
MDSO |
QMO |
Input | Output |
---|---|
Change request | Change request (updated) |
The change results as input to the SOP Software Development and is implemented accordingly.
This includes verification, validation and release activities while ensuring traceability. The relevant documentation is updated.
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