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Glossary Term
Design History File (DHF)
Definition
A Design History File (DHF) is a compilation of records that document the design and development process of a medical device. Required by the FDA under 21 CFR Part 820.30, the DHF demonstrates that the device was developed in accordance with design controls and meets regulatory and quality standards.
Relevance to the MedTech Industry
The DHF provides a comprehensive record of the design and development process, ensuring traceability, accountability, and regulatory compliance. It is essential for demonstrating to regulators that a device has been systematically and safely developed.
Additional Information & Related Terms
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