[ISO 13485 Cl 7.5.4] 

Clause 7.5.4 focuses on ensuring that the processes for servicing medical devices are well-documented, controlled, and effective. It essentially refers to the repair and/or maintenance of a medical device after it has been delivered to the customer.

The purpose of servicing activities is to maintain the safety and performance of the medical device and ensure the device continues to meet its intended use.

The organizations must document servicing procedures. This documentation should include Instructions on how to perform servicing activities, the necessary qualifications for personnel performing the servicing and the records that need to be maintained.

In ISO 13485:2016, requirement 7.5.4 defines servicing activities as the repair and/or preventative or routine maintenance of one or more parts in a finished device, post-distribution, to restore it to its safety and performance specifications.

For SaMD, the focus areas will be

• Bug fixes and patches to address software errors to ensure the functionality and safety.
• Software updates which implement new features or improvements to the SaMD, potentially impacting functionality or introducing new risks.
• Risk management activities which continuously assessing and mitigating potential risks throughout its lifecycle, especially after updates.
• Configuration management for controlling and tracking changes made to the software to ensure consistency and maintain traceability.
• Version control for maintaining a clear history of all software versions for rollback or reference if needed.