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ala26 replied to the topic Design Change Request in the forum Project Management Process and Medical Device Development 7 years, 2 months ago
At my company, the engineers also must redline the change they are making to the document. This is done online using microsoft’s track change. The newly edited document is than printed as a hard copy. If the newly edited document is checked as PMA, it is sent to someone from the headquarters of the company to approve. After it is approved, a pink sheet is attached to the old document as well as the new redlined document and sent to each department. The head of each department must sign it if he or she approves.