Hi Everyone,

This week, Dr. Simon talked about ECO’s (Engineering Change Orders) and how they are used to change something about the medical device after the design controls are finished. This can be a result of a few things, whether it is an error or a change in a regulation by the FDA or something else. From my experience, I have needed to use an ECO when a supplier of a raw material was no longer in business and we needed to find a new supplier of that material.

My question for you is:
What are some examples of a time or times that you have needed an ECO? What did you do to correct it?