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.
GOT QUESTIONS?
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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