MasterControl News Archive

Why Having End-to-End EDHR is crucial- and What It Looks Like
In medical device and diagnostic manufacturing, companies must keep complete and accurate device history records (DHRs). When using a paper-based or partially digitised system, maintaining complete and orderly records per U.S. Food and Drug Administration (FDA) 21 CFR Part 820 requirements can be an inefficient process with several common but unnecessary risks, resulting in product quality issues, recalls, warning letters, even consent decrees.