A design history file (DHF) is a collection of records that describe the design history of a finished medical device. The DHF may include records such as design inputs and outputs, engineering change orders, and design review documentation. The FDA specifies requirements for the DHF in Title 21 CFR section 820.30 as follows: 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.
The DHF should include design plans, drawings, design inputs and outputs, design review documentation, engineering change orders, and production transfer documents.
To create a DHF, compile the design control documentation in the following order:
Using an electronic system to create, track, and update the documentation will ensure that the DHF is always audit-ready.
The design history file is dedicated to documenting the device’s design history and ensuring that it was developed in accordance with the approved design plan. The device master record is concerned with the finished product and ensuring that all necessary items (i.e., components, packaging, labeling, maintenance procedures, etc.) are included.
See how Arena’s product-centric quality management systems (QMS) helps medical device companies manage the device master record and ensure compliance.
Arena PLM software streamlines product development so you can deliver products under budget and ahead of schedule.
Arena QMS helps you ensure regulatory compliance and faster delivery of life-enhancing products to your customers.
