Design history file example

What does the DHF contain?
A Design History File or DHF is the collection of records documenting all stages of the design phase.
The DHF shows the development process through the collection of drafts, detailing decision making, meeting notes, test data and reports that lead to the production and manufacturing of the final product..
What is DHF in QMS?
DHF is the design history file.
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 DHF..
What should be in a Design History File?
What belongs in your DHF? Your DHF should contain all of the documentation created during the product development phase of your medical device.
Following the mandated design controls process closely will help you understand what documents are required, as each step generates its own documentation..
According to FDA 21 CFR 820.30(j), a Design History File (DHF) is a compilation of records that carries the design history of a finished medical device.
The DHF includes all the necessary records to demonstrate that the device design was developed as per the approved design plan and requirements.
The design history file (DHF) is focused on capturing the history of the design and ensuring that it was done according to FDA regulation.
The device master record (DMR) is focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.

Dec 7, 2021A Design History File (DHF) shows the design history of a medical device. It is used to provide evidence that all the design control procedures How Does Design History File Design History File (DHF

Why A DHF Template Doesn’T Make Sense

The DHF is is intended to provide evidence of following an approved design plan, but the DHFconsists of many records–not just one record

Documenting Design Changes in Your DHF vs. A DMR Index

Product design changes that occur prior to the final design review and approval of commercial release are required for inclusion in the DHF

Design History File (DHF) Webinar

If you are interested in learning more about design history files, there is still time to register for today’s live training webinar

What are the requirements for a Design History File (DHF)?

The requirements for a design history file (DHF) are found in 21 CFR 820

30j: “Each manufacturer shall establish and maintain a DHF for each type of device

The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part

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What is a Design History File (DHF) for a medical device?

For example, a DHF for a medical device can include design inputs during a design plan

The design input can be a competitor analysis or the user experience from a similar product or job role

A well-organized Design History File (DHF) is mandatory for medical device manufacturers for designing a product that best fits the end user’s requirement

What is a design history file?

The documentation that comes out of design control procedures is collectively called the “Design History File” or DHF

Prior to starting development, manufacturers must develop a design controls process

Design Controls refer to actions taken by a manufacturer to control the design and development of a new medical device

A Touchstone file was originally a proprietary file format for the eponymous frequency-domain linear circuit simulator from EEsof, launched in 1984 and acquired by HP.
The simulator has been called HP/EEsof, then its engine has been successively included in the jOmega and ADS software suites and it is now owned by Keysight.