How to Manage Medical Device Design History File (DHF)?

25 Nov 2024

Developers must be very cautious when developing a QMS (Quality Management System) for a medical device. Developing and implementing such QMS demands lots of effort, and manufacturers may need to fulfill various regulatory requirements. In this blog, we will explore the FDA requirements concerning managing the Device History File (DHF).

The DHF is the documentation that entails all the details surrounding the design and development of the medical device.

Purpose of the DHF

The core purposes of the DHF are:

1. To show to the internal stakeholders and regulatory bodies that the device’s manufacturer(s) have complied with the design control process during the device’s development. 

1. To show that the medical device has been developed according to the design plan.

A DHF must fulfill these purposes. One to fulfill all the regulatory obligations concerning DHF is to keep a record of all the documentation. This is where strategies for managing the device history file come into play.

Having a DHF is also important because it contains all the materials that prove a device’s compliance with the regulatory requirements. Other than this, some basic documents that must be included in every DHF include:

• Design and development planning, including design plan documents, such as Gantt charts;
• Design outputs used by the manufacturer to build their device, including the procedure for defining and documenting design output compliance with this part, and the approved design output documentation itself
• User needs and design inputs defined by the manufacturer at the beginning of the project, including procedures for establishing design input that address the intended user needs and the approved design input documentation itself
• Design reviews concerned with design inputs and outputs, user needs, and design verification and validation, including the procedure for conducting reviews of the design process and any documentation related to the review
• Reports and protocols concerned with design verification and validation
• Any material(s) concerned with design transfer to manufacturing
• Design transfer to ensure that the design is accurately and effectively transferred into the product

Design changes, including the documented design change process

Such documentation must be done with care. For this purpose, we can break the process of managing device history into three simple steps:

Step 1: Building a traceability matrix

Step 2: Keeping the DHF updated across the product’s lifecycle

Step 3: Integrating DHF with risk management

Let’s break into these steps one-by-one:

Step 1 – Building the Traceability Matrix

The DHF of any product requires documentation for the following two parameters:

1. Product development
2. Design controls

A traceability matrix can help manufacturers ensure their documentation is well-connected and traceable. A traceable matrix visually represents links between different areas in a DHF, such as:

• Design inputs
• Design outputs
• User needs

And creates clear paths from the physical product to the design history.

The traceability matrix also helps manufacturers and device developers follow their device’s design history. Without it, they can easily miss crucial connections or events during the device’s design and development.

Developers often leave the development of their traceability matrices as a task for the end. However, this can lead them to miss critical steps. Therefore, the best strategy is to work on the traceability matrix early in development.

Step 2 – Keeping The updated across The Product’s Lifecycle

As per FDA’s requirements, all the medical device manufacturers

“Shall establish and maintain a DHF for each type of device.”

Although manufacturers keep updating their DHF as their product development progresses, there is still a chance that they will need to change it later. For example, they may need to modify it according to the post-market surveillance report (which comes forward after the device has been marketed).

For example, consider a device that has been marketed, but its post-market surveillance report has indicated the following two changes:

1. The manufacturer has to refine one feature concerned with the device’s design, and
2. They have to replace one material used in manufacturing their device with one of its safer alternatives.

Now, as the device’s developer incorporates these changes, they must ensure that they document them in their DHF, too.

Again, this proves the importance of having a traceability matrix at hand. In this scenario, the traceability matrix will show the design specifications and outputs that will be affected by these changes.

Important Notes:

1. The manufacturer must also document any new verification and validation activities they may have to execute due to these changes.
2. The DHF must be updated (as required) as long as the device remains on the market.

Step 3-Integrating DHF with Risk Management

For medical device manufacturers, it is crucial to know that risk management and design controls are intricately linked. Thus, they should be carried out together so that their device’s quality is not compromised.

To clarify this connection, let us first understand one aspect of each process.

• Performing risk control measures to reduce risks associated with any hazardous situation(s) identified with the product (risk management).

• Changing in design inputs and outputs so that risk reduction can be performed (design control)

Now, managing device history can be done via a digital paper approach or purpose-built QMS solutions. At TSQ&E, we aim to save our clients’ time and present them with solutions that fulfill their needs easily. If you are a medical device manufacturer who wants to fulfill the FDA’s requirements regarding DHF, then you should contact us. There, we can present you with optimal solutions to build and manage your DHF in line with FDA’s requirements. Our solutions will not only save you time, but they will prove to be more cost-effective than our competitors.