How to Create a Design History File (DHF) for Medical Devices
How to Create a Design History File (DHF) for Medical Devices
The Design History File (DHF) is a critical component of the medical device design and development process. Required by the FDA and other regulatory bodies, the DHF ensures that medical devices are designed in compliance with regulatory standards, ensuring safety and effectiveness. For anyone involved in medical device development, understanding the purpose, structure, and requirements of a DHF is essential.
This blog explores what a Design History File (DHF) is, why it's important, and how it supports compliance in medical device development. We’ll also provide actionable insights into creating and maintaining a robust DHF to satisfy regulatory requirements and streamline your device’s path to market.
What is a Design History File (DHF)?
A Design History File (DHF) is a collection of documents that demonstrate a medical device has been developed in accordance with a company's design plan and regulatory requirements. According to the FDA’s Quality System Regulation (QSR), 21 CFR Part 820.30, the DHF must include records of all activities and design outputs related to the development of the medical device.
DHF vs. DMR vs. DHR
Understanding the distinctions between these types of documentation is critical:
- DHF (Design History File): Focuses on the design and development process.
- DMR (Device Master Record): Contains instructions, drawings, and specifications for manufacturing the device.
- DHR (Device History Record): Documents the manufacturing history of a specific device or batch, ensuring it meets specifications.
Why is the Design History File Important?
The DHF serves multiple critical purposes:
- Regulatory Compliance: The medical device documentation contained in the DHF proves adherence to FDA standards, ISO 13485, and other global regulatory requirements.
- Quality Assurance: Ensures the device meets performance and safety standards through meticulous documentation.
- Traceability: Provides a clear traceable record of decisions, changes, and approvals throughout the design lifecycle.
- Market Approval: A complete design history file is essential for regulatory submissions, such as FDA 510(k) or PMA (Premarket Approval) applications.
- Risk Management: Supports risk analysis and mitigation activities by documenting safety evaluations throughout development.
- Design Knowledge Repository: Acts as a knowledge repository for future product updates or investigations.
FDA Design History File Requirements
The Design History File (DHF) represents the final step in the FDA's design controls process as outlined in 21 CFR Part 820. Unlike other compliance measures focused on policy and procedure creation, the DHF serves as an organizational record, ensuring design controls were thoroughly followed and documented during development. It is a critical part of the quality management system (QMS), and its accuracy, completeness, and organization are essential for successful FDA audits and regulatory compliance.
The FDA’s 21 CFR 820.30 on design controls requires these sections to be a part of the DHF:
Design and Development Planning
Manufacturers must create and update plans outlining design activities, responsibilities, and interdepartmental interactions. Plans must evolve and receive formal approval.
Design Input
Establish procedures to ensure design requirements meet user needs and intended use. Resolve ambiguities, and document and approve requirements.
Design Output
Define and document design outputs to confirm they meet inputs and ensure proper functioning, then document design output approvals.
Design Review
Conduct documented reviews at key stages, involving cross-functional teams and independent evaluators. Record results in the DHF.
Design Verification
Confirm outputs align with inputs, document methods and results, and include in the DHF.
Design Validation
Validate the design under actual or simulated conditions, ensuring it meets user needs and intended use. Record results in the DHF.
Design Transfer
Ensure accurate translation of the design into production specifications.
Design Changes
Establish procedures to document, review, and approve design changes before implementation.
ISO 13485 Requirements for a Design History File
As mentioned above, the Design History File (DHF) is a requirement under 21 CFR Part 820.30 in FDA regulations. While ISO 13485:2016 does not specifically reference the terminology "Design History File," it requires comprehensive documentation of the design and development process in section 7.3 and beyond. These requirements ensure traceability and compliance throughout the lifecycle of a medical device, aligning with the intent of the FDA's DHF requirements.
Building the DHF
Maintaining a process for compiling the DHF is vital for ensuring compliance and efficiency in medical device development. Here’s how to do it:
Establish a Design Plan
Develop a detailed roadmap outlining every stage of the design process, the team responsible, and the expected deliverables.
Standardize Documentation
Use templates and standardized formats for DHF documents to ensure consistency and completeness.
Integrate Cross-Functional Teams
Involve design, engineering, quality assurance, and regulatory teams in maintaining the DHF.
Utilize DHF Software
Consider using dedicated software tools to streamline the creation and management of the DHF. Features to look for include:
Conduct Regular Reviews
Schedule periodic reviews of the DHF to ensure it remains up to date and aligned with regulatory requirements.
Common Challenges in Managing Design History Files
Documentation Gaps
Failure to document activities or decisions can result in noncompliance and delays in regulatory approval.
Version Control
Managing multiple iterations of design documents without proper versioning can lead to confusion and errors.
Incomplete Risk Analysis
Neglecting to document risk management activities can leave significant gaps in the DHF.
Regulatory Complexity
Navigating evolving regulations requires constant attention and updates to the DHF.
What Would a Sample Design History File Include?
Design History File Example Structure
- Design and Development Plan
- A document outlining the overall strategy, timeline, and objectives for the design process.
- Example: A project plan detailing milestones, team responsibilities, and deliverables for SaMD development.
- User Needs and Design Inputs
- A record of user needs that translate into specific design requirements.
- Example: "The software must provide real-time glucose monitoring for diabetic patients, accessible via a mobile app."
- Design Outputs
- Tangible results of the design process, such as software architecture, source code, and user interfaces.
- Example: Screenshots of the SaMD user interface, system flow diagrams, and performance specifications.
- Risk Management Documentation
- Includes risk analyses, mitigation strategies, and compliance with ISO 14971.
- Example: A risk assessment identifying potential cybersecurity threats and detailing encryption measures implemented to mitigate them.
- Design Verification and Validation (V&V)
- Documentation proving the design meets user needs and intended use.
- Example: Test reports demonstrating that the SaMD accurately diagnoses conditions based on input data.
- Design Reviews
- Records of formal design reviews conducted at key milestones.
- Example: Meeting minutes summarizing stakeholder feedback and action items from a software prototype review.
- Traceability Matrix
- A visual or document showing the relations from design inputs to outputs, verification, and validation activities.
- Example: A matrix showing how specific software requirements are tested and validated during the development process.
- Software Lifecycle Processes
- Adherence to the ISO 62304 standard for SaMD lifecycle management.
- Example: Documentation of change control processes and maintenance plans for post-market updates.
- Final Design Documentation
- A comprehensive summary of the approved design, ready for submission to regulatory bodies.
- Example: A finalized version of the SaMD's system architecture and user manual.
Best Practices for Maintaining a Design History File
- Document Everything: Record every decision, activity, and approval, even if it seems minor.
- Prioritize Traceability: Ensure all documents are linked to specific design inputs, outputs, and changes.
- Train Your Team: Provide ongoing training for team members on the importance and requirements of the DHF.
- Use a Central Repository: Maintain a centralized location for all DHF documents to simplify access and audits.
The Design History File (DHF) is more than just a regulatory requirement; it’s a cornerstone of medical device design and development. A well-maintained DHF ensures compliance, facilitates regulatory approvals, and provides a roadmap for future device iterations.
By understanding the components of the DHF, ISO standards, and best practices, medical device manufacturers can streamline their development processes while prioritizing patient safety and product quality. Building a process for DHF creation is not just about meeting regulatory expectations—it’s about setting your device up for success in a competitive market.
How Ketryx can Help Companies with their Design History File
Ketryx simplifies and accelerates the creation and maintenance of the Design History File (DHF) by automatically capturing traceability across requirements, risks, tests, and design artifacts. It integrates seamlessly with tools like Jira, GitHub, and eQMS platforms, ensuring that all relevant records are synchronized and up to date. The platform’s automated documentation features reduce manual effort by linking updates across systems and generating export-ready DHF records. Ketryx also supports versioning and change management, making it easy to track iterations while maintaining compliance with FDA and ISO standards. And with Ketryx Intelligence, teams receive AI-powered proactive guidance to keep the DHF audit-ready at all times.
