Decoding The Three Ds of Product Development Lifecycle - DHF, DMR and DHR

In an effort to continuously improve the quality and safety of the medical devices being manufactured and sold, the Federal Drug Administration (FDA) mandates manufacturers to comply with regulations across the product lifecycle. It starts right at the beginning, at the design stage, and covers even the packaging, labeling, and post-market surveillance aspects.

In this journey, manufacturers have to deal with a lot of numbers and alphabets. The section numbers and subparts, as well as abbreviations such as DHF, DMR, and DHR! The fact that these three abbreviations look very similar and are very closely associated with each other does not help! But they are crucial and clarity in what is required and how to comply will help manufacturers not only be on the right side of the FDA, but also improve their own processes to be more time- and cost-efficient, reduce non-conformance, and improve customer satisfaction.

Explaining DHF, DMR, and DHR

First, let us start with the expansion of the three abbreviations:

• DHF - Design History File
• DMR - Device Master Record
• DHR - Device History Record

Design History File (DHF)

21 CFR Part 820 Subpart C outlines procedures that ensure the devices are designed to fulfill the objectives and meet the requirements. Called design controls, it covers the entire product design process from planning up to the validation of the design and finalizing the specifications. During the design process, there will be many iterations and changes, requiring repeated reviews, verification, and validation.

Capturing this entire process is a regulatory requirement to demonstrate that the design and development process complies with the approved design plan and the relevant regulation. The document that records the process is called the design history file or the DHF. In the absence of a DHF, the manufacturer is required to provide a reference to all the relevant records for device specifications, product process specifications, and quality assurance specifications. This can mean a whole lot of documents such as drawings, formulations, composition, equipment specifications, production procedures, and so on, used throughout the design process, including when transferring the design to the manufacturing team.

Therefore, creating a DHF is more efficient and also critical during the later stages, as we are about to see.

Device Master Record (DMR)

The DHF, the design history file, as we saw earlier, captured the device specifications, packaging and labeling specifications, and production process specifications, as well as the quality assurance requirements and specifications. The DMR, a requirement under 21 CFR Part 820.40, is a living document that has the current list of specifications and testing requirements. The device master record contains specifications for packaging and labeling, including methods and processes used, and procedures and methods for the installation, maintenance, and servicing of the product must be easily accessible.

The DMR can reference the DHF location, making diligence when creating the DHF important.

While DHF tracks the design history and its compliance with FDA regulations, DMR ensures that all the components needed to build, test, package, and service the device are ready and available.

Device History Record (DHR)

Now that the design and the components are ready, the next step is the actual manufacturing. The FDA requires manufacturers to establish and maintain procedures and document them in the Device History Record (DHR), which is extracted from DMR, for each batch to demonstrate conformance to the requirements and compliance with the regulations.

It aggregates DHF and DMR information and is a record of the device’s journey and must include information such as the manufacturing date, quantity, how much was distributed, the records demonstrating the acceptance of the device as being in conformance with the DMR, the primary identification label and labeling associated with each production unit; and the unique device identifier (UDI), universal product code (UPC), or any other identification(s) and control number(s) used.

Automation of these Documents: The Only Way to Ensure Efficiency and Correctness

The first and most complex and comprehensive document requirement is the DHF or the design history file. It is a detailed document that anticipates every stage of the product manufacturing process, from design to distribution. It includes the product design, the components and subassemblies to be used, the testing requirements, and the packaging and labeling information.

While it seems straightforward, a major part of design changes that impact specifications also happens at this stage. It needs every change to be reviewed and approved before it goes to manufacturing. Catching errors at this stage is better for the product than later, when it enters manufacturing or distribution.

A centralized, automated design process can make it efficient, facilitate collaboration between teams, identify risks early and put control measures in place to mitigate them. It helps with version control and ensures that the document is current and live, minimizing the risk of multiple versions floating around and causing inadvertent errors.

Systematic visibility to the DHF for DMR and DHR also becomes easy and increases compliance and conformance. It creates an audit trail that helps with traceability and accuracy.

ComplianceQuest’s Product Life Cycle Management (PLM) Software integrates Design Control and Quality Management, helping medical device manufacturers become compliant and efficient when designing and developing their products. Built on Salesforce, this cloud-based solution also integrates with enterprise systems such as SCM and ERP, thereby ensuring that all departments have the latest and relevant documents to enable them to work effectively and break barriers to innovation.

To know more about the ComplianceQuest PLM and how it can make you more compliant and reduce time to market, visit https://www.compliancequest.com/product-lifecycle-management-plm/