How to Prepare Your Design History File DHF for an FDA Inspection

Table Of Content

• iCat Solutions with fast eSTAR submission to successful FDA approval
• Design History File (DHF): What It Is & What Does It Include?
• Verification and Validation (V&V) documentation
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• Software to Manage Your Medical Device DHF
• In This Webinar, Learn About Integrated Risk Management for Medical Devices
• Design History File: What Your DHF should Include

While a bad DHF may not result in non-compliance, a good DHF can make the difference between a smooth compliance process and a bumpy one. To create a good DHF that streamlines compliance, design teams should know what to include—and what to avoid—as they go through the entire design and approval process. The FDA and other regulators are aware and recognize that medical devices will go through changes. All design changes must be documented using a design change process and documented the rationale for the change. In the pediatric example, design inputs to meet the user need for pediatric use could include specifications for a smaller patient, color choices to make the device more appealing to children, or weigh less than 3 pounds to be easily held by children.

iCat Solutions with fast eSTAR submission to successful FDA approval

These templates provide a standardized format for documenting and organizing the necessary information, ensuring that all required elements are captured consistently across different projects and products. From usability point of view, this phase needs to have documentation on the usability plan for both formative and summative evaluation. For this reason, an initial version of the labelling, IFU and other accompanying documents need to prepared and included in this phase. A digital document management system (DMS) which allows you to map out and link to all the documentary requirements of each phase of a project within a single digital view is an excellent way to meet the requirements of the DHF. Centralizing document and information control ensures a single source of truth, fortifying the DHF against inconsistencies and omissions.

Design History File (DHF): What It Is & What Does It Include?

Wound dressing firm warned for design, environmental control issues - Regulatory Focus

Wound dressing firm warned for design, environmental control issues.

Posted: Tue, 02 Nov 2021 07:00:00 GMT [source]

The following are some of the key requirements of the DHF that medical device organizations should take into account. Dior's "New Look" (that premiered in 1947) revived the popularity of girdles and the all-in-one corselettes. In the early 1950s, many couture houses used the interest in "foundationwear" to launch their own lines, soon after many lingerie manufacturers began to build their own brands. In 1957, Jane Russell wore the "Cantilever" bra that was scientifically designed by Howard Hughes to maximize a voluptuous look. The invention of Lycra (originally called "Fibre K") in 1959 revolutionized the underwear industry and was quickly incorporated into every aspect of lingerie. Madeleine Vionnet found her inspiration in ancient statues, creating timeless and beautiful gowns that would not look out of place on a Greek frieze.

Verification and Validation (V&V) documentation

While obeying imperatives that left little to the imagination of the couturier, Doucet was nonetheless a designer of immense taste and discrimination, a role many have tried since, but rarely with Doucet's level of success. The most obvious effect of the traditional approach design history as sequential, in which X begat Y and Y begat Z. This approach provides a framework for the process of design for any medical device. This "file" includes records such as the results of product testing, for example, at the end of production. Each unit (with the pharmaceutical products this would be each "batch"), is to be identified.

For standalone software the Device History Record will be slim, since there is no real production. However, the reproduction of data media or the distribution over downloads count towards the file. The Device History Record DHR finally provides evidence that one has produced the device in accordance with the requirements of Device Master Record and that it meets the requested acceptance criteria.

A Design History File (DHF) is used throughout the design and development process of a medical device. The final step in the FDA’s design controls process, as required by 21 CFR Part 820, is the creation of a DHF for the FDA. The Design History File is a crucial part of the FDA’s QMS (Quality Management System) requirements for design controls.

Rap music was a prominent influence on popular and street fashion during the early and mid-1990s. Followers of hip hop adopted huge baggy jeans, similar to those worn in American prisons, with big patterned shirts and heavy black shoes. The sports label Nike had great popularity, and materials such as Lycra/spandex were increasingly used for sportswear. Increasing eco-awareness and animal rights made even top couture houses such as Chanel introduce fake fur and natural fibers into their collections. The designers of Hollywood created a particular type of glamour for the stars of American film, and outfits worn by the likes of Marilyn Monroe, Lauren Bacall, or Grace Kelly were widely copied.

Think of it as the final stop for the information generated by all other design controls. An eQMS can help you maintain documentation at all phases of the design process, providing traceability between input requirements and output results. With features like document templates and revision control, you’ll be able to see how your documentation changes over time and easily identify when updates are made. Create procedures that identify how to document design and development activities.

These processes enhance patient safety and efficacy, providing evidence of compliance and adherence to quality standards. The DHF documents the risk analysis and mitigation strategies employed during the design and development process, ensuring that potential risks are identified, assessed, and managed effectively. By including risk management documentation, the DHF demonstrates compliance with risk management standards and regulatory expectations.

One of the most important things a medical device company can do to help bring products to market quickly is to stay organized. If your team isn't organized, you risk hurting product quality, not passing an audit and slowing production. Proper documentation is vital to organization, and, during the product design phase, that means creating and maintaining your Design History File (DHF). SimplerQMS provides you with tools to accelerate your product development following compliance requirements for life science organizations. The design control software module enables you to link the design and development documentation of each phase to its respective component. Design History File (DHF), Device Master Record (DMR), and Technical File (TF) can be easily maintained and sorted based on each product.

Implementing a robust design and development process, guided by an approved design plan, facilitates the creation of a well-documented DHF and a comprehensive DMR. This process should incorporate change management practices to adapt to design iterations and improvements effectively. Ensuring that all design outputs meet the approved design requirements is essential for maintaining product quality and safety, underscoring the importance of rigorous validation and verification activities. In summary, a Design History File (DHF)—sometimes called the Device History Record (DHR)—is a comprehensive documentation repository that captures and organizes information related to the product design and development of medical devices. It ensures compliance with regulatory requirements, provides traceability, and demonstrates adherence to design control processes and risk management. The DHF plays a crucial role in maintaining product quality, meeting regulatory expectations, and facilitating effective design control throughout the product development lifecycle.

SimplerQMS also allows the documentation to store in a single, centralized cloud-based system so that you can work location independently and access your documentation wherever required. The organization shall maintain a design and development file for each medical device type or medical device family. This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes. For a device master record (DMR), I recommend creating a DMR Index using a template that is organized in accordance with an international standard to meet the needs of a DMR and a Technical File. However, implementing digital documentation systems, as seen in the case studies, streamlines operations and eases the burden on development teams.

In this way a DHF can be much more than a static record of what has gone before, it can become an easily repeatable template for future success. Strategic planning becomes key to overcoming hurdles intrinsic to documentation processes. When constructing DHF components, it's vital to implement systematic approaches, such as checklists and templates, to streamline the creation and maintenance of accurate records. By utilizing an item-based approach for documentation and document creation, medical device software developers can further enhance the efficiency and accuracy of their DHF since documenting can become part of agile iteration cycles. This includes incorporating change control documentation to track modifications and updates throughout the device's lifecycle. Document control practices ensure a dynamic DHF that can adapt to ongoing design modifications and regulatory changes.