The Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are key regulatory documents in the lifecycle of medical devices, referenced under FDA 21 CFR Part 820.
A DHF is a compilation of records mandated by FDA 21 CFR 820.30 that documents a medical device’s design history, ensuring compliance with regulatory and customer requirements through consolidated design inputs, outputs, verifications, validations, and risk management. A DMR, required under 21 CFR 820.181, details the specifications and procedures for manufacturing a medical device, standardizing production to ensure quality and regulatory compliance. A DHR outlined under 21 CFR 820.184, captures the production history of a device, demonstrating it was manufactured according to the DMR.
The DHF focuses on the development phase, documenting how and why the design was created, while the DMR translates the final design into actionable manufacturing steps. The DHR ensures each unit or batch complies with the DMR and tracks production execution and results. Together, these documents are interlinked: the DHF informs the DMR, which guides the manufacturing process, and the DHR verifies compliance with the DMR.
Managing DHF, DMR, DHR effectively often involves Quality Management System (QMS) software. QMS solutions centralize document management, enhance traceability, integrate processes, and automate workflows, ensuring regulatory compliance and operational efficiency.
SimplerQMS offers QMS software for medical device companies, supporting the management of DHF, DMR, DHR, and various other QMS processes. Book a demo today to learn how SimplerQMS can optimize your operations and ensure compliance.
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 FDA 21 CFR 820.30.
The DHF is essential to prove that the medical device has been created and produced in compliance with customer and regulatory requirements. To demonstrate compliance with these requirements, all design-related paperwork, from preliminary ideas to final specifications, is captured. Furthermore, the DHF guarantees traceability by consolidating design inputs and risk analysis, outputs, verification, and validation records. To put it briefly, a robust DHF supports product efficacy, safety, and regulatory compliance across the course of the medical device’s lifecycle.
The term DHF is specifically used by the U.S. Food and Drug Administration (FDA). In FDA 21 CFR 820.30 (j) design history file requires that “each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”
The key components of the DHF are listed below.
- Design and Development Planning: Involves outlining the overall structure and approach for design activities to ensure each stage is fully coordinated and documented.
- Design Inputs: Represent the requirements the device must meet, including those derived from user needs, regulations, and market considerations.
- Design Outputs: These are the resulting deliverables—from specifications to blueprints—generated from the defined inputs.
- Design Review: A series of structured evaluations at different development stages to ensure requirements are met and potential issues are addressed early.
- Design Verification: Confirms that the design outputs match the specified design inputs. This uses objective evidence, such as test data.
- Design Validation: Verifies that the device meets user needs and intended uses under actual or simulated operating conditions.
- Design Transfer: Moves the final, approved design into production, making certain the manufacturing processes accurately reflect the design outputs.
- Design Changes: Implement procedures that clearly outline how design changes are identified, documented, validated or verified (as applicable), reviewed, and approved prior to their implementation. This ensures all modifications remain compliant and maintain product quality and safety.
What Is a Device Master Record (DMR)?
A Device Master Record (DMR) is a comprehensive collection of records that detail the procedures and specifications required to manufacture a medical device.
DMR centralizes all essential production records for a specific medical device. The DMR is used to standardize manufacturing processes, which in turn serves as the guide for ensuring consistent quality, regulatory compliance, and alignment with original design controls and intended use. The DMR is crucial for meeting FDA inspection requirements and translates design outputs into actionable, standardized instructions for production.
According to 21 CFR 820.181, “each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40.”
The device master record for each type of medical device shall include the key components listed below.
- Device Specifications: Includes drawings, composition, formulation, component specifications, and software specifications.
- Production Process Specifications: Contains equipment requirements, production methods, procedures, and environmental conditions.
- Quality Assurance Procedures and Specifications: Encompasses acceptance criteria and the necessary quality assurance equipment.
- Packaging and Labelling Specifications: Covers the methods and processes used.
- Installation, maintenance, and servicing procedures: These procedures outline the required steps and conditions for setting up, maintaining, and repairing the medical device over its operational lifespan.
What Is a Device History Record (DHR)?
A Device History Record (DHR) is a compilation of records containing the production history of a finished medical device.
DHR is required by the FDA under 21 CFR Part 820.184. 21 CFR Part 820.184 states that “each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part.”
The DHR serves as proof that the medical device was manufactured according to the specifications outlined in the DMR. Every manufactured medical device unit (lot or batch number) is necessary to satisfy all relevant specifications and other requirements and is demonstrated by DHR. During the production of each product, testing and quality control data are recorded to provide a transparent audit trail detailing the device’s manufacturing, inspection, and release dates. This documentation allows manufacturers, auditors, and regulators to verify product consistency, identify any discrepancies, and ensure compliance with established requirements.
The key components of DHR are listed below.
- The Dates of Manufacture: Specifies when production occurred.
- The Quantity Manufactured: Indicates the number of units manufactured.
- The Quantity Released for Distribution: Specifies the number of medical devices or units that have successfully passed all required quality checks, inspections, and testing during production and are approved for shipment to customers or distribution centers.
- The Acceptance Records: Documents whether the device or its components met the required quality control standards during and after production that are in accordance with the DMR.
- The Primary Identification Label and Labeling Records: These include copies of all device labels and their control numbers, ensuring traceability of each unit.
- Device Identification Number: Unique identifiers, also known referred by USFDA as any Unique Device Identifier (UDI) or Universal Product Code (UPC), and any other device identification(s) and control numbers used assigned to each device facilitate tracking and, if necessary, for recall procedures.
What Are the Key Differences Between DHF, DMR, and DHR?
The DHF, DMR, and DHR are critical documents in the medical device lifecycle where each have distinct functions within the framework of regulatory compliance.
Key differences between DHF, DMR, and DHR are outlined below.
- DHF: Focuses on how the device was developed. It compiles all design-related documents, showing that the device was designed in accordance with customer and regulatory requirements.
- DMR: Details how to manufacture the device. It contains or refers to all the guidelines, requirements, and processes required to guarantee that the equipment is manufactured consistently in accordance with its design.
- DHR: Demonstrates that each manufactured device meets the required specifications. It records the actual production data for each batch or unit produced, confirming compliance with the DMR.
A table summary comparing the DHF, DMR, and DHR is shown below.
| Aspect | Design History File (DHF) | Device Master Record (DMR) | Device History Record (DHR) |
|---|---|---|---|
| Purpose | Documents the design and development of the medical device. | Compilation of records for instructions and specifications for manufacturing the device. | Records the production history of a specific medical device or batch. |
| Focus | Design and development | Manufacturing process and controls | Production execution and results |
| Key Components / Contents | • Design inputs and outputs • Design verification and validation • Design reviews • Risk analysis | • Device specifications • Production processes • Quality assurance and control procedures • Installation, maintenance, and servicing procedures and methods • Packaging and labeling details • Sterilization and environmental controls | • Lot or batch number • Manufacturing dates • Inspection and test results • Device traceability (e.g., serial numbers) |
| Stage of Medical Device Lifecycle | Development phase | Production planning and execution phase | Post-production phase |
| FDA Requirement / Regulatory Reference | Required under 21 CFR 820.30 (Design Controls) | Required under 21 CFR 820.181 (Device Master Record) | Required under 21 CFR 820.184 (Device History Record) |
| Examples | • Validation reports • Verification reports • Design risk assessments | • Production specifications • Assembly instructions • Cleaning and sterilization processes | • Batch production records |
How Are DHF, DMR, and DHR Related?
The DHF, DMR, and DHR are interdependent elements that work together to ensure quality, compliance, and traceability during the design, manufacturing, and post-production stages of a medical device lifecycle.
The relationships between DHF, DMR, and DHR are outlined below.
- DHF to DMR: The DHF provides a comprehensive record of the design and development process of a medical device, documenting each phase from initial concept to the final design. Once the design is completed, the pertinent specifications and procedures are transferred to the Device Master Record (DMR), which provides detailed instructions on how to manufacture the device according to the approved design. Essentially, the DHF explains why the product is designed in a specific way, while the DMR translates that final design into actionable steps for production.
- DMR to DHR: The DMR outlines the precise specifications, procedures, and instructions for manufacturing the medical device. The Device History Record (DHR), on the other hand, serves as proof that each unit (or lot or batch) of the device was produced in strict adherence to the DMR instructions. In simpler terms, the DMR defines the manufacturing process, while the DHR confirms that the device was produced according to those defined specifications.
- DHF to DHR: The DHF outlines the complete design process, providing the rationale and supporting evidence for the development of the final product specifications. Meanwhile, the Device History Record (DHR) verifies that each unit (or lot or batch) of the finished product conforms to these established specifications. Simply put, the DHF explains why the device is designed in a particular way, while the DHR ensures it was manufactured according to that design.
The DHF, DMR, and DHR relationships are illustrated in the image below.
In the image above, the relationship between the DHF, DMR and DHR, the DHF captures the design journey, detailing the rationale and supporting evidence behind the final product’s specifications. The DMR defines the manufacturing process while the DHR confirms that the finished product (whether a single unit or a batch) conforms to those established specifications.
In this manner, the DHF explains the design choices, DMR instructs the manufacturing process while the DHR validates that the device was manufactured according to those choices.
Which ISO 13485 Medical Device Documents Relate to DHF, DMR, and DHR?
ISO 13485:2016 is the global standard for Quality Management Systems (QMS) in the medical device industry. It helps organizations ensure that medical devices are designed, produced, and distributed in compliance with customer and regulatory requirements.
While ISO 13485:2016 does not explicitly mention terms such as DHF, DMR, or DHR, it outlines the requirements for related documentation applicable to companies seeking compliance with the standard.
Alignment of DHR, DMR and DHR with the requirements of ISO 13485:2016 is listed below.
- DHF: Clauses 4.1.2 Generaland 4.2.3 Medical Device File include general documentation requirements that are applicable to DHR. 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) for planning of product realization wherein it mentions that records for evidence that product meet 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. Clause 7.5.9 Traceability addresses general traceability obligations for each design stage that extend to device history records as well.
- DMR: Clause 4.2.3 Medical Device File requires organizations to maintain one or more files for each medical device type or family. These files must contain or reference all necessary documents demonstrating compliance with international standards and applicable regulatory requirements. They should include a general description of the device, intended use, labeling, product specifications, and procedures for manufacturing, packaging, storage, handling, and distribution. Additionally, they must document protocols for measurement and monitoring and, where applicable, requirements for installation and service. In the EU, the commonly used term for this type of file is Technical File.
- DHR: Clause 4.2 Documentation Requirements, which covers how records (including production records) must be controlled and maintained. Clause 7.5 Production and Service Provision, particularly in the sub-clauses on process controls, identification, and traceability (7.5.8 and 7.5.9). These sub-clauses ensure that each device can be readily traced through the manufacturing process, supporting safety, quality, and regulatory compliance objectives. Furthermore, Clause 7.3.10 Design and development files of ISO 13485:2016 require organizations to maintain a design and development file for each medical device type or family, containing or referencing records that demonstrate conformity to design and development requirements and any related changes.
DHF, DMR and DHR regulatory requirements and document relationships are illustrated in the image below.
How Does QMS Software Help Manage DHF, DMR, and DHR?
QMS software is essential for managing the requirements related to design history files, device master records, and device history records in the medical device industry. QMS software supports medical device companies in meeting these requirements by offering a unified system for organizing, documenting, controlling, and tracking processes across the medical device lifecycle.
This software solution centralizes all design documents, automates the review process, and ensures compliance throughout the DHF management stage of product development. For DMR, it maintains accurate manufacturing records, manages equipment calibration, and enforces production quality compliance. In DHR management, it provides real-time tracking, automated approvals, and comprehensive traceability for regulatory adherence.
QMS software consolidates and links all relevant documents, such as design, manufacturing, and inspection records, in a single system. It provides robust traceability features to ensure devices are manufactured, tested, and distributed according to the approved design and production processes.
By simplifying and automating workflows, QMS software reduces manual effort and enhances efficiency while ensuring that processes adhere to required standards and regulations like ISO 13485 and FDA 21 CFR Part 820. Real-time data and insights enable organizations to make better, data-driven decisions.
Additionally, this tool supports risk management by offering tools to identify, assess, control, and monitor risks throughout the product lifecycle. It integrates processes across departments—such as design, manufacturing, regulatory, and quality assurance—to facilitate collaboration and adherence to standardized processes. These capabilities lead to improved process efficiency, fewer errors, and significant cost savings.
SimplerQMS offers QMS software for medical device companies, enabling streamlined management of DHF, DMR, and DHR. It provides robust document management, workflow automation, and additional functionalities such as training management, CAPA, and audit management. These features support compliance with regulatory requirements, including FDA 21 CFR Part 820, FDA 21 CFR Part 11, and ISO 13485:2016.
For companies aiming to enhance DHF, DMR, and DHR management efficiency and integrate other QMS processes, SimplerQMS delivers tailored solutions that improve operational efficiency and ensure regulatory compliance. Book a demo today to explore these capabilities.
