Engineering change orders provide documentation of corrective actions for faulty components, end of life components, or more efficient components in a medical product, ultimately increasing the product’s safety and efficiency. ECO can be used for components that need to be fixed or even recalled, for parts that are reaching their end of life because the manufacturer is either out of business or is phasing out the product, and for components that can be updated which will increase the product’s lifespan and reliability. ECOs are done by the operations department and take a very long time. I am sure this varies per product. What I have seen in the industry, for a blood glucose meter, and ECO takes minimally 8 weeks and that is if it is controlled and completed internally. If there is an outside party that is the legal manufacturer, then the ECO process takes much longer due to the communication and approvals needed between both companies. Project management can be very helpful in organizing the priority of ECOs depending on significance in change, the product’s priority, it’s intended use, and it’s market requirements.