Design History File Vs Technical File. We are designing and intend to manufacture a medical device delivering energy to the patient over intact skin. Fda's cgmps mandate design control and the design history file (dhf) at 21 cfr 820.30.
The aim of the technical file is to demonstrate the conformity of the product to the applicable requirements and eu medical device (or ivd) regulations. You are required to maintain a dhf for each type of device. It is required to get your device into europe and several other parts of the world.
The Design History File Cannot Just Represent The Last Stage Of Development.
European regulatory authorities require some sort of design history and it does not have to be a hugely Design history file (dhf) part v: The design history file 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 Contains Or References:
It should contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of the fda's. The very concept of fully documenting a design history file (dhf) is so far off the radar that it is rarely even considered at all. The aim of the technical file is to demonstrate the conformity of the product to the applicable requirements and eu medical device (or ivd) regulations.
In Fact, Design History Files Should Be ‘Living Documents’ In Just This Way.
A technical file is much closer in nature to a 510 (k) than a design history file. Currently they serve different purposes, support different goals, but the td is moving in the direction of the dhf. It includes documentation on the design transfer, the dhr (design history record) for the design transfer.
The Medical Device Design History File (Dhf) As The Name Implies, The Design History File Is Your Repository For All Records That Demonstrate Your Medical Device Was Developed In Accordance With The Approved Design Plan.
As fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specifications for the device and it does not take into consideration the design history. The cgmps mandate design control and the design history file (dhf). The cgmps mandate design control and the design history file (dhf).
Therefore, It Is An Important Initial Undertaking In The Quest For The Approval Of All Medical.
This phase corresponds to the transfer of the specification from the prototypes to the manufacturing process, so to have scalable process for production of the specific device. Rather, the design history file must document the course of development comprehensibly, for example how changes design changes (changes to the design) have been incorporated, released and implemented. The design history file, therefore, can become not just the repository for all your design and development documentation, but the organisational tool that helps you manage its assembly and keep required records of why, when and how design changes are made.