What is a Design History File (DHF) Index?
The purpose of a Design History File (DHF) is to provide a full history of the development process of a new medical device and are associated with device design controls. Use the template on the following page to create your DHF index. Think of it as a table of contents that outlines the development story ranging from user needs through design validation.
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Tips for Writing a DHF lndex:
- Breaking the DHF index into specific sections rather than a singular list enhances clarity, traceability and auditability.
- Structure the DHF index in a logical, sequential manner such that plans and input documents appear earlier and validations and design transfer appear at the end.
- Like all design documents, the DHF index is also subject to revision control. Ensure the DHF index revision is updated to coincide with document updates and change orders.
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FAQ About DHF Index
Here are some answers to frequently asked questions about DHF Index.
How does a DHF differ from a DMR?
How does a DHF differ from a DHR?
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