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bb254 started the topic Design Change Request in the forum Project Management Process and Medical Device Development 8 years, 2 months ago
Companies have different procedures in order to submit a design change request. Share your experience on the steps needed to complete a design change request at your company.
At Maquet, the engineers redline the latest version of a document as a hard copy. The co-op’s will then transfer the redlines onto an electronic copy using track changes or other software techniques. After the redline is complete a final version is created with the new revision level. Both the redline and final document are uploaded onto Getinge software called “TrackWise” under the file type of document record. The document record must be attached to a change notice document type in order to be considered as design change request. The change notice is sent to document control which approves or disproves of the changes. Once document control approves of the changes then a head from each department is obligated to sign off on the new changes. If a lead disapproves of the changes then the document returns back into the original state and the process must be completed again until everyone approves.