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 and regulatory …

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

May 29, 2024 · As you go through the design and development process for your medical device, the documentation that you create will be contained in your design history file, commonly abbreviated as …

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 company's …

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 medical device …

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 fit in.

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 product must …

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 simply require that …

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 medical …

This posts wants to provide an overview of the process of preparation of the design history file (DHF) for medical devices according to ISO 13485:2016 and other applicable regulations (such as 21 CFR 820).