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A structured document like a Design History File (DHF) is critical to medical device manufacturers. It is used to demonstrate safety and effectiveness and is essential to product development and regulatory submission process.
Today, leaders and decision-makers in the medical device sector are looking for greater collaboration between their engineering teams and quality/regulatory affairs leaders. Therefore, forward-looking medical device companies are looking to implement a cloud-based Product Design Management Solution that truly makes life easier for various stakeholders involved.
Specifically, they are looking to get products out to the market quicker and with greater quality performance. To do this right, they need a cloud-based Product Design Management Solution that keeps quality and engineering teams in sync. One key part of the overall product design process is design controls. In this page, we focus on one specific aspect of design controls, which is Design History File management.
According to FDA 21 CFR 820.30(j), a Design History File is a compilation of records that carries the design history of a finished medical device. This includes all the necessary records to demonstrate that the device design was developed as per the approved design plan and requirements and properly captured within the DHF document. DHF for medical device is also an important component of medical device design review. The design review results, including identification of the design, date of review, and the details of the individuals conducting the design review, are documented in the DHF.
DHF Management is a critical part of the design control lifecycle. Using a next-generation, cloud-based product design management solution, with a world-class Design Controls Solution, including DHF management, is extremely important.
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In an effort to continuously improve the quality and safety of the medical devices being manufactured and sold, the Federal…
The Digital Design History File (DHF) is a comprehensive electronic documentation system used in medical device manufacturing. It is a…
At ComplianceQuest, we spoke to various leaders in the medical device sector across quality, engineering and product teams. One of the biggest challenges with DHF management and overall management of the Design Controls process was the lack of easy collaboration and documentation nightmares. The need of the hour is to implement a solution where engineering, and quality, compliance & regulatory teams are in sync. Some of the key challenges faced concerning design documentation include:
Overwhelming documentation affects efficiency, which can lead to delays, mistakes, and non-compliance. Similarly, teams using paper-based documentation systems or spreadsheets face issues with version control, approvals, and revisions.Design History File of a medical device (DHF medical device) is a unified repository for all design documentation that is easily printable and remains accessible to all members.
Collaboration across departments, including engineering, quality, and regulatory, is cumbersome if critical tasks such as revisions or validations are done through spreadsheets. Manufacturers using a cloud-based design control system can store their DHF online for easy access.
A change in one component of the device can lead to a series of changes, tests, reviews, validations, and verifications. All these changes and updates can be tracked, documented, and approved in a single Design History File, according to regulatory standards.
When the number of stakeholders involved in a design process is high, there are various risks involved, from human errors to complex workflows. Using spreadsheets to identify and mitigate all risks increases the inherent risks in product development. DHF of a medical device acts as a single reference material to avoid mistakes in the manufacturing process.
Overwhelming documentation affects efficiency, which can lead to delays, mistakes, and non-compliances. Similarly, teams using paper-based documentation systems or spreadsheets face issues with version control, approvals, and revisions. DHF of a medical device is a unified repository for all design documentation that is easily printable and remains accessible to all members.
The design history file is a critical component of FDA 21 CFR Part 820.30, which governs design controls for medical devices. According to FDA regulations, each manufacturer must establish and maintain a DHF for every type of device they produce. The DHF serves as evidence that the design process complies with the approved design plan and regulatory requirements.
Key FDA requirements for a DHF
The Design and Development File should also connect with the broader Medical Device File, which contains or references the approved documentation needed to demonstrate that the device meets applicable quality, product and regulatory requirements.
As outlined in 21 CFR Part 820 – Quality System Regulation, the FDA mandates the following for a compliant DHF:
Design Control Documentation
The DHF must include all records that demonstrate the device was developed by planned design controls to ensure compliance with regulatory and statutory requirements.
Complete Record Keeping
Manufacturers must maintain or reference all relevant design and development documents, including:
Accessibility and Maintenance
The DHF must be maintained throughout the product’s lifecycle and remain readily accessible for FDA audits and regulatory inspections.
ComplianceQuest’s Design Controls solution gives medical device manufacturers complete visibility over the product design process. With the cloud-based solution, teams can easily collaborate and design high-quality products while remaining compliant with FDA and ISO regulations.
A medical device DHF template is a structured outline that helps development teams organize design and development records consistently across a project, so nothing gets lost or left untraceable as a device moves from concept to market. A template acts as an index or checklist, not a rigid form: it points to where each type of record should live and how they connect to one another.
There is no single mandatory DHF format required by regulators. The structure should be adapted to the specific device, its risk level, the development process used (e.g., waterfall, agile, iterative), and the applicable regulatory requirements for the target market. What matters is completeness and traceability, not adherence to one fixed template.
A typical DHF index generally includes:
The best DHF management software supports the complete design control process, not just document storage. A system that only stores files still leaves teams manually tracking traceability, approvals, and change history outside the tool, which is exactly where compliance gaps and audit findings tend to originate.
Good DHF software should help teams organize and maintain both Design History File and Design and Development File records, and link approved records into the broader Medical Device File (MDF), so design, quality, and regulatory documentation stay connected rather than existing as separate, disconnected repositories.
Use the following checklist when evaluating DHF management software:
FDA QMSR and ISO 13485 support
Design control workflows and traceability
Look for built-in traceability linking user needs → design inputs → design outputs → verification → validation → risk controls. This matters because manual traceability (spreadsheets, matrices maintained outside the system) is one of the most common sources of audit findings; gaps appear whenever a requirement isn't cleanly linked to its verification evidence.
Document control, approvals, e-signatures, and audit trails
The system should support electronic signatures, version control, and a complete, tamper-evident audit trail for every document. This matters because DHF records must demonstrate not just what was decided, but who approved it, when, and under what version, a requirement regulators check closely during inspections.
Security, integrations, migration, reporting, and scalability
Evaluate the platform's security certifications, its ability to integrate with existing engineering and business systems, migration support for legacy records, reporting capabilities, and whether it can scale as your device portfolio grows. This matters because a DHF system that works for one device line but can't scale across a growing product portfolio becomes a bottleneck rather than a solution.
Implementation, validation, and vendor support
Consider the vendor's implementation process, whether the software itself is validated for use in a regulated environment, and the level of ongoing support provided. This matters because a compliance software solution that isn't itself properly validated can become a liability during an audit, rather than an asset.
Verification, validation, and design change management
The platform should support structured V&V protocols and formal change control, including impact assessment and re-verification triggers when a change affects prior work. This matters because unmanaged design changes are a leading cause of technical debt and untraceable gaps in the DHF.
There's no single, universal checklist for what goes into a Design History File (DHF) or Design and Development File (DDF), the exact contents depend on the device's risk classification, the development process used, applicable regulatory requirements (FDA QMSR, ISO 13485, EU MDR), and the complexity of the design itself. That said, most DHFs share a common backbone of records that trace a device from user need to finished, verified design.
As per the FDA 21 CFR Part 820.30, subsection (j), DHF must contain
According to ISO 13485:2016, the medical device manufacturer must include the following details in the DHF:
Simply put, a Design History File contains all the steps and processes performed during the design phase of a medical device and forms the basis of a compliant DHF medical device. DHF acts as a guideline for manufacturing a medical device.
We’ve been working with ComplianceQuest for about one and a half years (and going). The software itself is very well designed and will help any organization to satisfy QMS requirements. It fits hand in hand with SFDC platform and leverages all that cloud can offer. The software is very intuitive and users can be trained fairly easily. The CQ team is very knowledgeable and provided customization services tailored to our needs. I would recommend them 100%.
Andi Xie,Quality Engineer
FDA 21 CFR 820.30 is applicable to Class I, II, and III device manufacturers. As per the regulation, manufacturers must establish and maintain procedures to control the design of the devices so as to ensure that specified design requirements are met. There are various phases of design control, each having its own set of requirements and regulations that must be met to remain FDA compliant.
Design and development planning describes the design and development process based on interaction with various groups. The plan also defines the responsibility for implementation.
Design input focuses on the device requirements and ensures that the manufacturing process addresses the intended use of the device, including the needs of the patient.
Design output emphasizes the proper functioning of the device and if it conforms to the design input requirements.
Design review is conducted at every design development stage to ensure the design results are as per plan.
Design verification and validation establish and maintain procedures for verifying the device design. It is performed under defined operating conditions on initial production units or batches.
Design transfer is done to avoid any miscommunication in translation in device design. This step checks if all the design specifications are mentioned in the production specifications.
Design changes include procedures that are used to identify, document, validate, verify, review, and approve changes in design before actual implementation.
A design history file (DHF) is a record that holds all the information for compliance and to ensure the design was developed based on the approved design plan.
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Design History File (DHF): According to FDA 21 CFR Part 820.30, DHF is the record that holds all the details necessary to demonstrate that the design was developed in accordance with the approved design plan. DHF contains all the details from the design and development process, inputs, outputs, verification and validation, reviews, transfers, and changes.
Device Master Record (DMR): FDA 21 CFR Part 820.40 focuses on the Device Master Record. A DMR must be created for each type of device, including device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation and maintenance methods.
Device History Record (DHR): Device History Record (DHR) includes the dates of manufacture, quantity manufactured, quality released for distribution, acceptance records, primary identification label, and UDI or IPC.
The Design History File (DHF) is one of the first documents an FDA inspector will ask for during an FDA audit. To that end, it is the duty of the internal team to keep the file always up to date. A DHF audit is an internal audit performed to ensure that all elements of the design process are complete and present within the file. A DHF audit can be performed using CQ’s Product Design Management Solution. Using the solution, an auditor can focus on verifying two areas of a Design History File (DHF)
Product Assessment to ensure all product-related risks, with risk assessment and classification, are documented.
Product Risk Control to understand if the various risk control measures, verifications, and residual risk analysis are correctly captured.
DHF remediation is the process of reviewing and correcting an existing Design History File to ensure it fully meets FDA 21 CFR 820.30 and ISO 13485 requirements. It’s essential for closing compliance gaps, avoiding FDA findings, and ensuring regulatory submission readiness.
You should begin DHF remediation when design documentation is incomplete, during pre-audit preparation, after FDA or ISO audit findings, or when legacy devices need updates to meet current regulatory standards.
An audit-ready DHF has complete, unbroken traceability from user needs through design inputs, outputs, verification, and validation, with no orphaned requirements or unresolved design changes. It also has a clear, chronological change history, documented risk management records tied to specific design decisions, and evidence that every design review and approval was formally recorded, not just informally discussed.
The software should support 21 CFR Part 11–compliant electronic signatures (unique user credentials, signature manifestation, and a documented signing meaning) along with a complete, immutable audit trail that captures who made each change, what was changed, and when without the ability to alter or delete that history after the fact.
Modern DHF platforms are generally designed to integrate with adjacent systems, PLM for product/engineering data, ALM for software development records (relevant for devices with embedded software), and ERP for manufacturing and supply chain data, so design records stay connected to the systems where the underlying engineering work actually happens, rather than requiring manual re-entry.
Migration typically involves digitizing paper records (scanning with appropriate metadata tagging), mapping legacy electronic records into the new system's structure, and validating that traceability links carry over correctly rather than breaking during the move. Because DHF completeness is safety-critical, migration projects generally include a verification step confirming no records were lost or mis-linked in the transfer.
A DHF should be updated continuously throughout active development, whenever a design input, output, verification result, or risk assessment changes, rather than compiled retroactively at the end of a project. After a device reaches market, the DHF/DDF is updated any time a formal design change occurs, including changes prompted by post-market surveillance findings.
A Medical Device File (MDF) is a broader record than a DHF. It includes the DHF/DDF as one component but also covers documentation across the full product lifecycle, such as manufacturing records, labeling, post-market surveillance data, and regulatory submissions. The DHF documents how the device was designed; the MDF documents the device's complete regulatory and quality history.
They serve the same core purpose of documenting the design control process, but the terminology differs by region. "Design History File" (DHF) is the term used under FDA regulations (21 CFR 820.30, and now QMSR), while "Design and Development File" (DDF) is the terminology used under ISO 13485 and EU MDR. In practice, most manufacturers build a single file structure that satisfies both naming conventions, since the underlying required content overlaps significantly.
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