The medical device industry landscape is ever-changing owing to globalization and the advent of newer technologies. Due to these constant changes and developments, medical device organizations need robust change management systems.

A change can be prompted at various stages of the medical device life cycle. Some of the common events that can act as ‘triggers for changes include the following:

  • Changes related to the quality system, either documentation or specific processes
  • Changes related to the design of the device on the market, such as equipment changes, supplier changes, raw material changes, testing protocols changes, labeling changes, etc.
  • Changes in applicable Regulatory requirements
  • Changes related to the product range, such as the upgradation of existing or new products
  • Customer complaints & service records
  • When detected quality errors through corrective and preventive actions

Such changes lead to modifications in the existing system, obsolescence of the existing system, or the addition of a new system. It is a Regulatory requirement to maintain the traceability of changes by documenting them, so they can be  easily monitored through this process.

This article discusses the five (05) key steps of the change management process, from proposal for the implementation of change to post-implementation review.

Proposal and Evaluation 

Whenever a change is proposed, or the change initiator identifies a need, the details such as change proposal, goals/objectives behind the proposed changes, justification, change classification into significant or nonsignificant, and action plans are documented and presented to the QA team and impacted department/s.

The proposed changes can be categorized into significant, nonsignificant or major and minor. Major changes impact the device safety or affect the product in the market. Major changes require extensive planning and documentation changes which may have a huge impact on the related process. Major changes require reporting to and getting approval from Health Authorities/ regulators before implementing the changes. Minor changes could be more administrative or with limited impact on related processes.

Impact Assessment and Risk Assessment

The change initiator, along with a qualified team, assesses the impact of the change on the quality management system, product function, usability, safety, intended use, and the impact on Regulatory filling. Classification of change triggers the need for risk assessment. It is carried out to determine overall risk and the impact it can have on the impacted process. A risk mitigation strategy is drawn up by the QA and technical team.


After evaluation and risk assessment, the QA team and designee will evaluate the need for proposed changes. Upon scrutiny, the proposed change can either be approved or rejected. The approved changes will proceed to implementation, and the rejected changes will be recorded with a justification of rejection, and the record will be closed.


After the change has been approved, the implementation phase begins. The processes carried out during the phase are carefully monitored and documented by the QA team and designated personnel. As mentioned previously, documentation is crucial to ensure traceability. Training for the impacted department members is carried out for the implemented changes.

Post-Implementation Review

After the change has been implemented, the QA team and designee evaluate if the change implemented has met desired goals and objectives. If it is determined that the change has been successfully implemented, the change order is closed.

Major or minor changes can have implications for all the stakeholders of a business, and therefore, it is paramount to ensure that the changes implemented are communicated effectively. By having thorough change management systems in place, companies can adapt quickly to new developments and gain a competitive advantage. 

To know more about change management and other quality management requirements, contact Freyr today!


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