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I work for a mid-sized medical device manufacturer and am the sole documentation specialist for the organization. We have a difference of opinion on whether our change control documents should be called Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/DCO).
The rationale for ECO is that it seems to be the familiar term used by larger medical device companies while the DCO would be more appropriate for changes made outside the engineering area, such as Marketing, Finance, etc. which have nothing to do with Engineering.
Is one more appropriate than the other for a Medical Device Manufacturer? We are currently using ECO and all our documentation references that.
Thank you.
The rationale for ECO is that it seems to be the familiar term used by larger medical device companies while the DCO would be more appropriate for changes made outside the engineering area, such as Marketing, Finance, etc. which have nothing to do with Engineering.
Is one more appropriate than the other for a Medical Device Manufacturer? We are currently using ECO and all our documentation references that.
Thank you.