Design History File (DHF)
A Design History File (DHF) is a technical document to document the design and development process of a medical device.
- Context:
- It can contain:
- a Design and development plan: an overview of the overall plan for the design and development of the medical device.
- a Design inputs document: Describes the user needs, product requirements, and any other specifications for the device.
- a Design outputs document: Describes the design documents, drawings, schematics, and other outputs that demonstrate how the device meets the design inputs.
- a Design verification and validation document: Describes the testing and verification activities conducted during the design and development process.
- a Risk management document: Describes the risk management activities and processes, including hazard analysis and risk assessments.
- a Change control document: Describes any changes made to the design during the development process and how they were managed and controlled.
- a Design reviews document: Describes all design reviews conducted throughout the design and development process.
- a Design transfer document: Describes the processes and procedures used to transfer the design to manufacturing.
- a Design history summary document: Describes a summary of the entire design and development process, including any issues or problems that arose and how they were resolved.
- a Device labeling and packaging document: Describes the labeling and packaging used for the device and how it meets regulatory requirements.
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- It can contain:
- Example(s):
- Counter-Example(s):
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- See: Quality Control, Document, Medical Device, U.S. Congress, Patient, U.S. Food And Drug Administration.
References
2023
- chat
- A Design History File (DHF) is a comprehensive record-keeping system used by medical device manufacturers to document the design and development process of a medical device. The DHF is a key component of the medical device development process and is required by regulatory agencies, such as the US Food and Drug Administration (FDA), to ensure that medical devices are safe and effective for their intended use.
The DHF typically includes all of the documentation related to the design, development, and testing of the medical device, including design inputs and specifications, design reviews and verifications, risk management plans and analyses, and design changes and updates. It also includes documentation related to the manufacturing and quality control processes used to produce the medical device, such as production process specifications, equipment maintenance records, and product testing and inspection records.
The DHF is an important tool for ensuring that medical devices are developed and manufactured in accordance with applicable regulations and industry standards. By maintaining a complete and accurate DHF, medical device manufacturers can demonstrate that their products are safe, effective, and of high quality, and can help to expedite the regulatory review and approval process.
- A Design History File (DHF) is a comprehensive record-keeping system used by medical device manufacturers to document the design and development process of a medical device. The DHF is a key component of the medical device development process and is required by regulatory agencies, such as the US Food and Drug Administration (FDA), to ensure that medical devices are safe and effective for their intended use.
2023
- chat
- A Design History File (DHF) is a comprehensive document that contains all the information related to the design, development, and testing of a medical device. It is a critical record that demonstrates that the device has been designed, manufactured, and tested in accordance with regulatory requirements and quality standards.
Here are some sections that should be included in a Design History File (DHF):
- Design and development plan: This section should provide an overview of the overall plan for the design and development of the medical device.
- Design inputs: This section should detail the user needs, product requirements, and any other specifications for the device.
- Design outputs: This section should contain all the design documents, drawings, schematics, and other outputs that demonstrate how the device meets the design inputs.
- Design verification and validation: This section should include all the testing and verification activities conducted during the design and development process.
- Risk management: This section should document the risk management activities and processes, including hazard analysis and risk assessments.
- Change control: This section should detail any changes made to the design during the development process and how they were managed and controlled.
- Design reviews: This section should include records of all design reviews conducted throughout the design and development process.
- Design transfer: This section should detail the processes and procedures used to transfer the design to manufacturing.
- Design history summary: This section should provide a summary of the entire design and development process, including any issues or problems that arose and how they were resolved.
- Device labeling and packaging: This section should detail the labeling and packaging used for the device and how it meets regulatory requirements.
- It's important to note that the specific requirements for a Design History File may vary depending on the regulatory requirements and quality standards of the country or region where the device will be sold.
- A Design History File (DHF) is a comprehensive document that contains all the information related to the design, development, and testing of a medical device. It is a critical record that demonstrates that the device has been designed, manufactured, and tested in accordance with regulatory requirements and quality standards.
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Design_history_file Retrieved:2022-9-15.
- A design history file is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device.
2019
- https://www.greenlight.guru/blog/design-history-file-dhf-device-master-record-dmr-device-history-record-dhr
- QUOTE: ... The medical device industry has a lot of acronyms.
The terms DHF, DMR, and DHR (which stand for Design History File, Device Master Record, and Device History Record, respectively) have had associations with design controls for some time now, but the similarity of letters in each respective name is enough to cause ongoing confusion among medical device professionals.
To make matters worse, these three aspects of design controls are quite closely related and share a lot of similarities. We’ve created this article to clarify the differences between DHF, DMR, and DHR. Let’s begin. ...
- QUOTE: ... The medical device industry has a lot of acronyms.
2010
- (Lincoln, 2010) ⇒ John E. Lincoln. (2010). “Medical Device Development under Design Control.” In: Journal of Validation Technology, 16(1).
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- Design control and design history file (DHF) requirements of the good manufacturing practice (GMP) guidelines were initiated by FDA in 1996-1997
- Medical device design control begins somewhere between research and development when senior management makes a medical device research effort a formal project and begins to budget or make major expenditures for commercialization
- … The formal design control and design history file (DHF) requirements of the GMPs were initiated by the FDA in 1996-1997 (2). Progressive companies were already enacting these …
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