Feb 3, 2025 · A Design History File (DHF) is a structured compilation of records documenting the design and development process of a medical device, ensuring adherence to design controls …

A design history file is a compilation of documentation that describes the design history of a finished medical device.

Jan 15, 2025 · What is a Design History File (DHF)? A Design History File (DHF) is a collection of documents that demonstrate a medical device has been developed in accordance with a …

Aug 27, 2025 · What is a design history file? A design history file contains all the designs and updates of a medical device during its lifetime. It contains all the necessary data to show that a …

The design history file (DHF) is a formal, organized documentation of all the product design and development processes pertaining to a finished medical device. The creation of a DHF is the …

This guide breaks down everything you need to know about assembling a Design History File, from key ingredients and audit prep to where your device master records and history records …

The Design History File (DHF) is a complete history of the development of new and modified products and processes. Once a DHF is created for a product, subsequent changes to the …

Sep 22, 2025 · What Is a Design History File (DHF)? Complete 2025 Guide. A Design History File (DHF) is a mandatory compilation of records documenting how a medical device was designed …

Aug 6, 2024 · DHF is an acronym for design history file. The US FDA is the only country that specifically includes this in medical device regulations (i.e., 21 CFR 820.30j). Other countries …

What is a Design History File (DHF)? A Design History File’s definition is a set of documents that serves as a comprehensive record of a medical device’s design and development planning. A …