Creation of a Design History File (DHF) Per 21 CFR 820.30
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The creation of a Design History File (DHF) Per 21 CFR 820.30
The creation of a Design History File (DHF) is the last step in the design control process mandated by the U.S. Food and Drug Administration (FDA) in 21 CFR Part 820. While most of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards, the DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development.
