A Design History File or DHF is the collection of records documenting all stages of the design phase. The DHF shows the development process through the collection of drafts, detailing decision making, meeting notes, test data and reports that lead to the production and manufacturing of the final product. The DHF should layout the drafting process in chronological order for ease of understanding and clarity. As part of the regulatory process and good manufacturing practices, a DHF may be required for a certification mark, as the DHF will show the product has been scrutinized and rigorously tested to meet quality control standards.
What is a Design History File (DHF)?
A Design History File (DHF) is a comprehensive document that serves as a repository of information, records, and documentation related to the design and development of a medical device or new product for a life sciences company. Directly related to the Device Master Record (DMR), the DHF is a critical component of the Design Control process within a quality management system (QMS) for medical device companies and medical device manufacturers.
The DHF captures the entire lifecycle of a medical device, from its initial concept through development, validation, and post-production activities. It encompasses all relevant design and development documentation, providing traceability and ensuring compliance with regulatory requirements, such as 21 CFR Part 820 in the United States.
The DHF includes various elements and documents, including design changes, development plans, design specifications, design inputs, design outputs, design verification, design validation, design review records, risk analysis, acceptance criteria, labeling, and other essential design control procedures. These documents collectively demonstrate that the medical device has been designed, developed, and validated according to the appropriate regulations and standards.
The DHF plays a crucial role in regulatory compliance and meeting the requirements of regulatory bodies such as the Food and Drug Administration (FDA) for medical device design. It provides evidence of adherence to design controls and regulatory guidelines throughout the medical device development and overall product development process. Compliance with international standards, such as ISO 13485:2016, further ensures the effectiveness of the DHF in maintaining quality and meeting regulatory requirements.
The DHF ensures that all design activities are properly documented, including design changes and updates. It records the rationale, decision-making process, and impact of design changes, enabling traceability and facilitating effective change management. This documentation is vital for maintaining the integrity of the design and ensuring that design changes are properly evaluated, validated, and implemented.
Design verification and validation activities are crucial components of the DHF. Verification ensures that the design outputs meet the specified design inputs, while validation ensures that the device performs as intended in the target user environment. The DHF captures records of these activities, including test results, protocols, and reports, to demonstrate that the device has been thoroughly tested and meets the necessary quality and performance requirements.
Risk management is an integral part of the DHF. The DHF documents the risk analysis and mitigation strategies employed during the design and development process, ensuring that potential risks are identified, assessed, and managed effectively. By including risk management documentation, the DHF demonstrates compliance with risk management standards and regulatory expectations.
Stakeholder involvement is crucial throughout the development process, and the DHF captures the input and feedback from stakeholders. This may include user needs, customer requirements, and feedback from healthcare professionals, patients, and regulatory authorities. The DHF ensures that these inputs are properly considered and incorporated into the design and development activities.
The DHF also facilitates the transfer of the design to the production process. It includes documentation related to design transfer activities, ensuring that the design is effectively communicated to manufacturing and enabling the production of devices that meet the specified design requirements.
To ensure consistency and efficiency, organizations often develop DHF templates or standard operating procedures (SOPs) that guide the structure and content of the DHF. These templates provide a standardized format for documenting and organizing the necessary information, ensuring that all required elements are captured consistently across different projects and products.
The DHF serves as a critical reference document for audits, inspections, and regulatory submissions. It provides a comprehensive record of the design and development activities, enabling regulatory agencies to evaluate compliance with applicable regulations and standards. Organizations can use the DHF to demonstrate the safety, effectiveness, and quality of their medical devices during regulatory reviews and inspections.
Webinars, training courses, and other resources are available to support organizations in understanding and implementing effective DHF practices. These resources provide guidance, practical examples, and best practices to ensure that the DHF is properly established and maintained throughout the product development process.
In summary, a Design History File (DHF)—sometimes called the Device History Record (DHR)—is a comprehensive documentation repository that captures and organizes information related to the product design and development of medical devices. It ensures compliance with regulatory requirements, provides traceability, and demonstrates adherence to design control processes and risk management. The DHF plays a crucial role in maintaining product quality, meeting regulatory expectations, and facilitating effective design control throughout the product development lifecycle.