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SOP Change Management

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.

Process Steps

1. Creation of Change Request

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.

Anyone in the company with a change proposal
Input Output
Change proposal Change request

2. Evaluation of Change

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.

Head of Software Development
Product Manager
Input Output
Change request Change request (updated)

3. Implementation, Verification, Validation, Update of Documentation

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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