Demystifying Engineering Change Control in the Medical Devices

Change is an inevitable part of the medical device manufacturing industry. In order to stay compliant with regulations, improve product quality, and respond to market demands, companies must effectively manage change control and engineering change order processes. This blog aims to provide insights into change control, engineering change control, and the role of Engineering Change Orders (ECOs) in the change management process. Additionally, we will explore the challenges faced by companies in managing these changes and the importance of simplifying the process using Lean documents and lean configuration.

Understanding Change Control 

Change control is a systematic approach to managing changes in a controlled and efficient manner. It encompasses identifying, documenting, evaluating, approving, and implementing changes to products, processes, or documents. Change control ensures that changes are properly assessed for their impact, risks, and benefits, and that they are implemented in a controlled and traceable manner.

Keys to Effective Change Control Management in Medical Device Manufacturing

Managing change control effectively is crucial for medical device manufacturers. Here are some key principles to consider: 

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