Design history file
From Wikipedia, the free encyclopedia
 |
This article is orphaned as few or no other articles link to it. Please help introduce links in articles on related topics. (August 2006) |
 |
This article may require cleanup to meet Wikipedia's quality standards. Please improve this article if you can. (August 2006) |
Design History File (DHF) is a document or documentation artifact used in the Medical Device industry.
The DHF was introduced in 1990 when the US Congress passed the Safe Medical Devices Act. This legislation gave the Food and Drug Administration (FDA) [1] the authority to monitor and regulate Medical Device companies new product development processes. Prior to this legislation, FDA auditors were limited to examining the Production and Quality Control records.
The Regulation requires of Medical Devices manufacturers of Class II and Class III devices to implement Design Controls. These Design Controls consist of:
- a Development and Control plan used to manage the development of a new Product and
- a Design History File where these activities are documented.
These controls are specifically intended to manage a Medical Device companies Product Development (PD) activities aimed at developing and introducting new Products. Research and Development (R&D) processes aimed at developing new underlying technologies are not subject to these regulations.
The requirements for a DHF are documented in FDA Regulation 21 CFR. The following is an overview of the key parts of a DHF.
Contents |
[edit] Design Input
Design Inputs are typically the initial Requirements that describe the Medical Device to be produced.
[edit] Design Output
Design Outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. Including the manufacturing process and the in-coming, in-process and finished device inspection, measurement or test methods and criteria. The outputs are normally documented in models, drawings, engineering analysis and other documents.
The output needs to be directly traceable to the input requirements. Design Verification and Validation should demonstrate that the final output specifications conform to the input requirements and meet user needs and intended uses.
[edit] Design Review
The Design Review is a formal review of the Medical Device design by representatives of each design function participating in the design efforts as well as other interested parties (e.g. Marketing, Sales, Manufacturing Engineering, etc.). The Design Review must be documented in the DHF and include Review Date, Participants, Design Version/Revision reviewed and Review Results.
[edit] Design Verification
Design Verification is the process that confirms that the Design Output conforms to the Design Input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design Verification must be documented in the DHF and include the Verification Date, Participants, Design Version/Revision verified, Verification Method and Verification Results.
[edit] Design Validation
Design Validation is the process in which the Device Design is validated using initial/low volume Production processes. The purpose for the Design Validation is to confirm that the Design functions according to Design Inputs when produced using normal Production Processes rather than Prototype processes. The Design Validation must be documented in the DHF.
[edit] Design Transfer
Design Transfer is the process in which the Device Design is translated into Production, Distribution and Installation specifications.
[edit] Design Changes
Design Changes is the process in which the Design changes are identified and documented. Also known as Engineering Change or Enterprise Change.
[edit] Design History File
The DHF is a formal document that is prepared for each Medical Device. The DHF can be either a collection of the actual documents generated in the PD process or an index of documents and their storage location.
A much more detailed description of these requirements may be found in FDA guidance documents, 21 CFR 820. [2]
