DHF, DMR and DHR Differences

May 21, 2025 | Lorraine Caputo, Lumanity

What's a Design History File (DHF)?

The Design History File captures the history of the design and ensures that it complies with FDA regulations. It serves as proof to auditors that the design process has been controlled according to the specified regulations. The DHF includes comprehensive documentation of design decision-making history, risk management activities, change control procedures, validation reports, clinical data and regulatory communications.

What's a Device Master Record (DMR)?

On the other hand, the Device Master Record can be considered the official "recipe" for manufacturing a medical device. It outlines how the device must be built, packaged, labeled, tested and maintained. As a required output of the design process, the DMR must be transferred to production. It should be updated whenever there are changes or improvements to the device or manufacturing process to ensure consistent production quality and regulatory compliance. A typical DMR also encompasses device history records and other supporting documentation.

What's a Device History Record (DHR)?

The Device History Record contains detailed information about everything done to make the device. It provides proof that the device was manufactured according to design specifications and the DMR. According to the FDA, the DHR should include thorough documentation, and manufacturers should maintain procedures to ensure DHRs are kept for each batch, lot or unit. The DHR is essentially the history of the device, much like the DHF is the history of its design.

Summary of DHF, DMR and DHR differences:

DHF: Focuses on capturing the history of the design, ensuring that the design process meets regulatory standards.
DMR: Focuses on the 'recipe' to build, test, package, and service the device, ensuring that manufacturing is consistent and meets quality standards.
DHR: Documents the history of the device's manufacture, proving compliance with the DMR.

What regulations require DHF, DMR and DHR?

In the United States, Food and Drug Administration regulations for medical device manufacturers, specifically 21 CFR Part 820. Together, the DHF, DMR and DHR form the backbone of FDA QSR compliance. ISO 13485, international standards for medical device quality also require a "design and development file," similar to the DHF.

Proper organization and management of these records are crucial for compliance. It is often recommended to use an automated electronic quality management system (eQMS) to avoid disorganization and errors. require the establishment and maintenance of these design files.

FDA's final rule aligning the QSR with ISO 13485:2016

On January 31, 2024, the FDA issued a final rule to amend its Quality System Regulation (QSR) under 21 CFR Part 820, aligning it with the international standard ISO 13485:2016 for medical device quality management systems. Now called the Quality Management System Regulation (QMSR), this updated regulation harmonizes U.S. standards with global ones, aiming to enhance the quality, safety and effectiveness of medical devices. The new rule goes into effect on February 2, 2026, allowing manufacturers time to comply with the current QS regulation until then.

Importantly, this amendment does not alter the record-keeping requirements, which remain consistent with those under ISO 13485. While terms like DMR, DHR, and DHF might no longer appear in the regulations, organizations can continue using them internally, ensuring everyone understands the associated documentation and records.

Why you need an electronic Quality Management System (eQMS)

Managing complex and constantly evolving documents, such as product requirements and designs, is challenging and involves many people. Without proper document controls, the Device Master Record (DMR) can become chaotic, leading to misplaced or overwritten documents. Basic tools like DropBox lack integrated change control processes, making it difficult to manage changes effectively. An eQMS can automate change control, reducing errors and ensuring all changes are properly authorized and tracked.

DMR documents contain crucial links and shared data that need to be maintained accurately. An electronic Quality Management System (eQMS) keeps these links intact and ensures any authorized changes are system-wide, which isn’t possible with basic tools like Google Drive or DropBox.

A compliant DMR begins with QT9 QMS, offering several advantages:

Enhanced Accuracy: Automation minimizes human errors, ensuring information is consistently accurate and up-to-date.
Improved Efficiency: Automated systems streamline document creation, updates and retrievals, saving time and resources.
Better Traceability: Automated DMRs provide a clear audit trail, simplifying change tracking and regulatory compliance.
Centralized Access: Digital systems allow centralized storage, facilitating easier access and collaboration for team members.
Regulatory Compliance: Automated systems ensure all necessary documentation is current, aiding in regulatory audits.

It is more essential than ever for medical device manufacturers to adopt an electronic quality management system (eQMS) to maintain the Device Master Record (DMR). An eQMS ensures that DMRs are accurately and efficiently managed, keeping up with regulatory requirements and facilitating easier compliance. The system can automate document control, change management and audit trails, which are critical for adhering to the new, rigorous standards. Therefore, implementing an eQMS is vital for manufacturers to stay compliant with the evolving regulatory landscape and maintain the integrity of their DMRs.

Conclusion

Lumanity specializes in providing comprehensive solutions to help medical device manufacturers set up and maintain an effective electronic quality management system (eQMS). Our team of experts understands the intricacies of regulatory compliance and the importance of seamless document management. We offer tailored eQMS implementation services that ensure your Device Master Record (DMR) and other essential documents are systematically organized, easily accessible and fully compliant with the latest FDA regulations and international standards like ISO 13485. With Lumanity's guidance, you can streamline your quality management processes, reduce the risk of errors and enhance overall operational efficiency. Partnering with Lumanity means you can confidently navigate the complexities of regulatory compliance while focusing on what you do best—delivering high-quality medical devices.

QT9 QMS software for medical device compliance

QT9 QMS offers an end-to-end solution for addressing the challenges of compliance and quality management in the medical device industry. QT9 QMS offers more than 25 modules that come standard, including:

Document Control
Risk Management
Audit Management
Employee Training
Supplier Management
Customer Feedback
Product Design Controls

QT9 QMS also offers electronic Device History Records (eDHR) and Device Master Records (eDMR) with one click using a simple QT9 QMS and QT9 ERP integration. Take advantage of QT9’s free validation and a dedicated compliance portal for securely sharing DHR and DMR records with auditors.

QT9 QMS is a fully validated, highly rated eQMS that is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool. QT9’s user-friendly interface and no-nonsense licensing lets medical device companies focus on getting quality, life-changing products to market faster.

About the Author:

With over 20 years in the Quality Management space, Lorraine Caputo is a seasoned expert in regulatory compliance and product safety.

Lorraine has successfully implemented quality management systems across various organizations, enhancing product standards and operational efficiency. Her dedication to the field is evident in her ongoing efforts to stay updated with the latest industry advancements and regulatory changes. As a Certified Quality Auditor, she brings a meticulous approach to auditing and improving quality processes within the industry.