Design History File (DHF): Definition and Requirements

A Design History File (DHF) is a structured compilation of records documenting the design and development process of a medical device, ensuring adherence to design controls and regulatory requirements. The DHF is mandated by FDA 21 CFR Part 820.30 for compliance with U.S. regulations and is comparable to the “design and development file” required by sub-clause 7.3.10 of ISO 13485:2016.

The DHF includes documentation such as design plans, inputs, outputs, reviews, risk management, verification, validation, and design transfer records. It ensures traceability and compliance throughout the device’s lifecycle. Effective DHF management involves centralized document control systems, regular audits, and strong document control procedures to maintain accessibility and traceability.

The DHF differs from the Device Master Record (DMR), which contains manufacturing instructions, and the Device History Record (DHR), which captures production details. Together, they ensure compliance, quality, and traceability for medical devices.

Digital solutions, such as document management software, have capabilities such as automating workflows, maintaining version control, and streamlining DHF documentation processes.

SimplerQMS offers medical device QMS software, including robust document management capabilities for managing DHF documentation more effectively. You can book a demo to see how SimplerQMS streamlines DHF management and various other QMS processes.

What Is a Design History File (DHF)?

Design History File (DHF) is a compilation of organized records that describes the design history of a finished medical device according to 21 CFR 820 of USFDA (2024). This file serves as a comprehensive and complete archive that demonstrates the medical device was developed in accordance with the predefined design controls and requirements.

The term “Design History File” is specifically used by the U.S. Food and Drug Administration (FDA) to describe this documentation. In the context of international standards, specifically ISO 13485:2016, the DHF is comparable to what is known as the “design and development file.” The design and development file similarly documents all activities and procedures involved in the design and development of a medical device, ensuring that the device satisfies the customer and regulatory requirements applicable in international markets.

What Does a Design History File (DHF) Include?

A Design History File (DHF) includes design plans, reports, minutes from meetings, design reviews, and other types of test findings. The DHF captures how a medical device was conceptualized, developed, tested, and prepared for manufacturing.

Beyond ensuring regulatory compliance, the DHF is essential for maintaining the medical device’s integrity and validation throughout its lifecycle.

To create a DHF, companies must gather and organize all relevant documentation starting from the initiation of the device concept through to its final design validation. The process begins by defining the scope, which depends on the device’s type and intended use. When establishing the scope, it is important to consider regulations and standards, such as FDA 21 CFR 820.30(j) and ISO 13485.

All files must be maintained in a centralized, version-controlled system to ensure accessibility and traceability. Through workflow automation and the integration of associated operations, digital solutions like quality management software can expedite the processing and filing of DHFs. Lastly, during the product lifespan, the DHF should be reviewed, approved, and updated often to take into account any modifications or new information.

Each document within the DHF serves to adhere to both regulatory and customer-imposed requirements, demonstrating the device is developed with due diligence. For Contract Development and Manufacturing Organizations (CDMOs), it is especially important to include customer-specific requirements in the DHF.

What Are the Phases of the Design Control Process?

The phases of the design control process are listed below.

• Design and Development Planning: Defining the structure and approach for design activities, ensuring all stages are seamlessly coordinated and well-documented.
• Design Inputs: Identifying the requirements the device must fulfill, including those driven by user needs, regulatory guidelines, and market demands.
• Design Outputs: Creating deliverables derived from the design inputs, such as specifications, blueprints, and prototypes.
• Design Review: Performing systematic evaluations at various design stages to verify compliance with requirements and address potential issues early. A key milestone during this phase is when the design is locked in verification and validation or the concept more commonly known in the medical device industry as “design freeze”. Any changes afterward require detailed review and strong justification.
• Design Verification: Demonstrating, through testing and objective evidence, that the design outputs align with the specified design inputs.
• Design Validation: Confirming that the device satisfies user needs and its intended use, under actual or simulated operational conditions.
• Design Transfer: Moving the finalized design into production, ensuring accurate implementation of all design outputs in manufacturing processes.
• Design Changes: Handling updates to the design post-release, ensuring they comply with all requirements and are meticulously documented.

DHF remediation is not a formal part of the standard design control phases but is instead an activity that may be undertaken during or after the design control process if deficiencies in the DHF are identified. For example, DHF remediation is integrated into Design Review checkpoints or handled as a standalone quality assurance process, particularly when audits or assessments uncover issues. This is a continuous approach to maintain compliance and traceability throughout the product lifecycle.

The flowchart below illustrates the medical device design control process, highlighting all the design control phases and integrating the waterfall methodology.

SimplerQMS allows the organization of views and collections of DHF components—design inputs/outputs, verification/validation documents, and design review records—alongside related documents like risk management files, the Device Master Record (DMR), and other technical files within a centralized folder system.

What Are the FDA Requirements for a Design History File (DHF)?

The key FDA requirements for a DHF, as per 21 CFR Part 820 – Quality System Regulation, specifically FDA 21 CFR Part 820.30, are listed below.

• Design Control Documentation: The DHF must include records showing that the design was developed in accordance with planned design controls, ensuring compliance with regulatory and statutory requirements.
• Complete Record Keeping: The DHF must contain or reference all relevant and up-to-date documents detailing the design and development process, including design plans, inputs and outputs, review records, verification and validation documentation, as well as design changes.
• Accessibility and Maintenance: The DHF must be maintained throughout the product’s lifecycle and be readily available for regulatory authorities to review and verify compliance.

What Are the Other Design and Development Requirements?

Additional design and development requirements are outlined in several clauses of ISO 13485:2016, including Clause 4.1.2 (General) and Clause 4.2.3 (Medical Device File). Both clauses detail general documentation requirements that align with the U.S. FDA’s Design History File (DHF) requirements. Additionally, clause 7.3.10 Design and development files, outlines additional design and development requirements for medical devices, stating that manufacturers must maintain a design and development file for each device or device family.

Furthermore, another relevant clause is 7.1(d) wherein it mentions that records for evidence that product meets requirements shall be maintained. Clause 7.5.8 Identification requires organizations to document procedures for identifying products throughout their realization, including a system for unique device identification if mandated by regulatory requirements. Section 7.5.9 Traceability addresses general traceability obligations for each design stage that extend to device history records as well.

Moreover, the design process must also account for customer requirements, including custom specifications or performance criteria. For example, in contract development and manufacturing organizations (CDMOs), it is essential to document and maintain customer specifications to ensure that devices are developed in alignment with customer requirements.

How to Manage DHF Documentation More Effectively?

Some ways to manage DHF documentation more effectively are listed below.

• Adopt a Centralized Document Management System: Adopting a centralized document management system can streamline the organization and storage of DHF documents by efficiently managing different document versions—such as “draft,” “review,” and “approved”—and ensuring that all documents are easily accessible and stored in the correct versions.
• Conduct Audits and Reviews: Performing audits and reviews of the DHF ensures that the documentation remains complete and in compliance with regulatory requirements. This practice helps identify any gaps or discrepancies that need to be addressed.
• Implement Document Control Procedures: Implementing strong document control procedures is crucial, as these procedures should outline how documents are created, reviewed, approved, updated, and archived, ensuring that only current and approved documents are utilized throughout the design and development process.
• Link with Other Records: The DHF together with key records like the Device Master Record (DMR) and Device History Record (DHR) can be linked to maintain consistency and ensure traceability across all documentation related to the medical device.  
• Train and Communicate to the Team: It is essential to train all team members or process owners on the significance of the DHF and proper documentation procedures, while also communicating and training them on any updates or changes to documentation practices to ensure adherence to company protocols regarding the DHF.
• Utilize Digital Tools: Utilizing digital tools and document management software or QMS software solutions can simplify the management of DHF documentation as these tools can automate various aspects of design control.

How Does a DHF Differ from a Device Master Record (DMR) and a Device History Record (DHR)?

The Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are collections of documents in the medical device lifecycle, each serving distinct roles and containing different types of information.

A design history file is a collection of records that document the design and development process of a medical device. It provides a comprehensive, chronological history of design, including design inputs, outputs, reviews, and verification and validation activities. The DHF ensures that the device was developed in compliance with design controls and regulatory requirements.

The device master record is the “blueprint” for manufacturing the device. It includes product specifications, manufacturing processes, quality assurance procedures, and packaging and labeling requirements. The DMR is derived from the DHF and serves as the guide to ensure that every unit produced meets the same standards and specifications.

The device history record captures the production history of each device or batch. It includes data on manufacturing, testing, and inspection dates and processes. The DHR record verifies that the device was made according to the DMR and allows traceability of any issues back to the specific batch or unit.

In essence, the DHF documents the design process, the DMR provides manufacturing instructions, and the DHR records the actual execution of these instructions. Together, they ensure the safety, quality, and regulatory compliance of medical devices.

Learn more about the differences and relations between DHF, DMR, and DHR in our dedicated article.

What Is the Role of Document Management Software in Managing DHF Documentation?

Document management software is an efficient tool for managing Design History File (DHF) documentation. Document management software for medical device companies offers powerful features that streamline and secure the handling of important documents. Often integrated into modern QMS solutions, this software is essential for medical device companies to ensure compliance and improve operational efficiency.

The main capabilities of document management software in managing DHF documentation are listed below.

• Version Control: Ensures only current, approved documents are used, access control to maintain data integrity and confidentiality
• Audit Trails: Tracks document revisions and approvals for regulatory compliance
• Automated Workflows: Streamline document review and approval
• Integration Capabilities: Seamless connection with other QMS processes.
• Access Control: Regulates who can view, edit, or approve documents, which is crucial for maintaining the integrity and confidentiality of sensitive design data.
• Assigning Unique Document ID: The document is given a unique identification number to set it apart from the others, regardless of whether it is a component of the Device Master Record (DMR), Design History File (DHF), or other important records. This special ID ensures that the right version is being utilized by acting as a reference number that makes it simple to monitor, trace, and recover the document.
• Electronic Signature: DHF documentation can be approved more quickly with electronic signatures. In addition, this is not just to save time but is also compliant to that is compliant with 21 CFR Part 11 and EU Annex 11 to guarantee the validity and security of electronic signature usage in the organization.

Robust document management capabilities that streamline the management of DHFs are a part of modern QMS software solutions. SimplerQMS offers comprehensive QMS software for medical device companies, featuring advanced document management capabilities. This software supports an extensive range of QMS processes and helps ensure compliance with customer and regulatory requirements such as FDA 21 CFR Part 820 and ISO 13485:2016, among others.

With SimplerQMS, medical device companies can efficiently manage their DHF documentation, ensuring comprehensive documentation of all design and development activities while maintaining compliance with industry-applicable requirements. The system also enables tracking of activities related to DHF creation, allowing for easy monitoring of progress. Additionally, features like document due dates and automated email notifications help keep the process on track.

See it for yourself – learn how SimplerQMS can improve the management of your DHF documentation and streamline all the other QMS processes. Book a personalized demo and talk with our Quality Solution experts.