When changes occur throughout the design and the development processes, the organization is required to control them. The changes shall be evaluated whether they affected any aspect of the product and already delivered products.

The purpose of controlling the changes is to ensure that any changes are accepted by the relevant functions.  Changes shall be:

• Identified – the medical device and the relevant components are identified.
• Reviewed and examined – there is a clear definition of who shall review and examine and what shall he review and examine. This is a very hard requirement to follow because the types of requested changes are almost infinite.
• Verified and validated – the changes are to be verified and validated in order to examine whether the changes affect other components within the medical device. As well, the organization is required to evaluate the affect of the changes on medical devices that has already been delivered to customers and how one can update these devices so they would compare with the new revised ones. 
• Approved – there is a clear definition of who shall approve the changes.

Changes in the medical device specification shall be performed so the consistency of the requirements and other development component (such as test specifications, development environment instruction guides, etc.) would be maintained. 

A good example would come out of the software industry. Any change on any of the software components may affect the other component of the software and consequently the medical device would fail to deliver the requirements. Therefore it is required to review and evaluate the effect of the change for all of the software components, to validate the change and to approve it. In some cases it may be referred as configuration management:

• Sole identification of the product and any of the components
• Identification of editions for any component
• Identification of the developing status for every status
• Control of configuration – when several people work independently on the component
• Identification, tracing and reporting for all components for all activities following the demand for a change
• Evaluation of the changes - status, verification and validation
• Releasing the component for use