Glossary Term
Engineering Change Order (ECO)
Definition
An Engineering Change Order (ECO) is a formal document used in product development and manufacturing to authorize, implement, and record modifications to a medical device's design, materials, components, or manufacturing processes. ECOs ensure that changes are properly reviewed, approved, and documented to maintain compliance, quality, and traceability.
Relevance to the MedTech Industry
ECOs are critical for managing changes in the development and production of medical devices, ensuring that updates improve functionality, safety, or efficiency while maintaining regulatory compliance. They help manufacturers adapt to evolving requirements, user feedback, or new technologies without compromising product integrity.
Additional Information & Related Terms
Examples of Situations Requiring an ECO
Updating a device’s design to improve usability or safety.
Changing a component material due to supplier discontinuation.
Modifying manufacturing processes to address production inefficiencies.
Implementing feedback from clinical evaluations or user complaints.
Related Terms
Design Controls The framework for managing changes during the design phase, often triggering ECOs.
Change Management A broader process encompassing ECOs to ensure consistent implementation of updates.
Design History File (DHF) A repository that tracks all design changes, including ECOs, throughout the product lifecycle.
Corrective and Preventive Action (CAPA) May initiate ECOs to address identified issues or risks.