The Predetermined Change Control Crisis: Why Your Medical Device Now Requires a Change Plan Before It Gets Changed
SEATTLE — Dr. Aris Thorne, senior regulatory affairs officer at MedCorp Dynamics, stands before a whiteboard that reads “MODIFY THIS? FILL FORM 12B-Ω FIRST” in bold black marker. Behind him, a sleek new defibrillator sits on a cart, waiting to do its job or not, depending on paperwork completion.
“For the first time in human medical device history,” Thorne explains, adjusting his spectacles, “we must document what changes we will make before we actually make them. This is the Predetermined Change Control Plan (PCCP), and without it, your defibrillator can’t save a heart. It just… sits.”