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Rob Packard from Medical Device Academy discusses the distinctions between document change control and design change control processes. He highlights a common mistake among clients who, while learning document change control for their new quality systems, overlook the specific needs for design change control, particularly since many are introducing medical devices for the first time. Packard emphasizes that while it may seem logical to apply document control processes to approve various changes, the nuances of design changes—such as modifications to devices, manufacturing processes, or suppliers—require a distinct approach. Proper understanding and application of each process are crucial for successful market entry.
