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  Design Controls  >  Design History File (DHF) for Medical Device

Design History File for Medical Device

DHF Design History File for Medical Devices

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.

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DHF Design History File for Medical Devices
dhf medical device video

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.

What is a Design History File for a Medical Device?

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. 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.

design history file
What is DHF in medical devices?

What is DHF in Medical Devices?

The FDA 21 CFR 820.30 mandates that all Class 2 and 3 medical devices establish and maintain procedures to control the design of medical devices. To that end, each manufacturer must establish and maintain a Design History File for each type of medical device. Design History File (DHF) demonstrates design traceability throughout the entire product development process of the medical device. All medical device manufacturers must maintain DHF as regulated by ISO 13485:2016. All medical device manufacturers must ensure that their documentation is up to date and readily available for regulatory inspection.

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What Are Some of the Key Challenges That Can Be Overcome with Better Digital Transformation of Design History File Management?

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:

documentation

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 is a unified repository for all design documentation that is easily printable and remains accessible to all members.

collaboration

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.

track changes

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.

design process

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.


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  • documentation

    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.

  • collaboration

    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.

  • track changes

    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.

  • design process

    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.

FDA Guidelines and Requirements for a Design History File for Medical Device

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

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:

    • Design and development plans
    • Design inputs and outputs
    • Design review records
    • Verification and validation documentation
    • Design changes and revision history

  • Accessibility and Maintenance

    The DHF must be maintained throughout the product’s lifecycle and remain readily accessible for FDA audits and regulatory inspections.

With ComplianceQuest, medical device companies can streamline DHF compliance, improve audit readiness, and maintain a structured approach to design history documentation.
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How Does a Next-Gen Platform Like CQ Help with Design History File Management?

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.

  • CQ’s Product Design Management solution enables design leaders to collaborate with their team for critical tasks such as revisions or validations using the easily accessible design history files. The solution allows users to assign and track actions for individual team members based on deliverables. With built-in collaboration tools such as Chatter and Design Review management, teams can interact in real-time while maintaining documentation of project progress.

  • CQ’s Design Controls solution offers design teams a unified repository to store all design documentation, including device requirements, deliverables, and changes. By creating a single source of truth, all departments involved can be in sync with the complete document stack.
  • Design leaders can use CQ’s Design Controls solution as an end-to-end design project management tool to assign actions to team members, follow up on delivery time, and keep track of all deliverables during all the various stages of the design lifecycle with advanced list views and Gantt charts.
  • CQ’s Product Design Management solution includes a Design History File that can be used to track, document, and approve all changes and updates according to regulatory standards. The solution with built-in revision controls ensures that the design files also include approvals, signatures, revisions, and meeting notes.
  • Manage Design review meetings with CQ’s design controls solution. Schedule meetings to assess project progress, assign and easily track assigned actions during meetings, and document meeting minutes automatically for full traceability.

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How Does ComplianceQuest’s Design Controls Solution, Including DHF Management, Help Various Stakeholders?

Design Engineers

Design engineers can gain complete real-time visibility over the product design development process and simplify documentation for their teams so they can focus on innovation. The cloud-based solution allows the DHF of a medical device to be accessed from anywhere, anytime.

Quality Leaders

Quality leaders can use the solution to ensure that all quality processes and procedures are easily implemented throughout development efforts, along with comprehensive and up-to-date documentation. Quality teams can also get approvals and complete documentation instantly.

Regulatory Assurance Team

The Regulatory Assurance Team can readily prepare for DHF audits as there is no risk of non-compliance. Management can also easily keep track of all regulatory standards and audits.

Reducing IT Time and Cost

The IT team does not have to spend time connecting various ERP and QMS Systems, as CQ’s Design Controls Solution effortlessly integrates. This helps reduce IT costs and improve product quality with a comprehensive and systematic approach to product development.

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Design Quality: Connecting Design to Documentation

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What Design Components Are Required to Be in the Design History File for medical device?

approved design plan
approved design plan

As per the FDA 21 CFR Part 820.30, subsection (j), DHF must contain

  • An approved Design Plan
  • Every document that proves the conformity of the product with the approved design plan
design requirements documents

According to ISO 13485:2016, the medical device manufacturer must include the following details in the DHF:

  • Design parameters (design plan) for every medical device type
  • All documents conform to design requirements
design requirements documents
steps and process for design history file
steps and process for design history file

Simply put, a Design History File contains all the steps and processes performed during the design phase of a medical device. DHF acts as a guideline for manufacturing a medical device.

  • User requirement specifications
  • System architecture
  • Software architecture
  • Component drawings
  • Risk analysis and risk assessments
  • System tests
  • Component tests
  • Validation activities


Great software with a great team to back it up with!

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 — provided customization services tailoring to our needs.Would recommend 100%.

Andi Xie,
Quality Engineer

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What Are the Requirements for Compliance with FDA 21 CFR 820.30 Design Control?

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 strong> emphasizes the proper functioning of the device and if it conforms to the design input requirements.

  • Design review strong> is conducted at every design development stage to ensure the design results are as per plan.

  • Design verification strong> 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 strong> 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 strong> include procedures that are used to identify, document, validate, verify, review, and approve changes in design before actual implementation.

  • A design history file (DHF) strong> is a record that holds all the information for compliance and to ensure the design was developed based on the approved design plan.

Manage Your Entire Design Control Lifecycle with ComplianceQuest’s Cloud-Based Design History File Management for Hassle-Free Approvals

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Frequently Asked Questions

    • 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.

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