As mentioned above and within Dr. Simon’s video, the ECO is required when the design controls are finished and the device needs a change. With this, it may create more modifications within the regulatory aspect such as SOP changes, additional work in verification, risk analysis, and even animal studies. And requiring those changes to be added into the 510K or PMA as supporting documentation. Also, a company initiating the ECO must take into account is disposition which means any product that has been manufactured or sold that does not contain the change. If device is in market do you sell it all or do a recall? For the product in stock, do you try to re-work what you can or scrap entire lot.