Aug 31, 2021 Ezra Kelderman

What is a Device History Record (DHR)?

What is the best way to ensure that your medical device has been built with quality in mind?

Many industry-leading medical device manufacturers rely on the device history record (DHR) to keep tabs on any changes to the overall design of a product and prevent major deviations from one production batch to the next.

And if achieving all the medical device regulatory compliance is a sticking point for your life sciences startup or scale-up, building a well-organized and complete DHR is one of the easiest things you can do to identify major quality issues and activate appropriate corrective and preventive actions (CAPA).

Keep reading to learn more about what a device history record is and how you can go about building one.

Overview: What is the Device History Record (DHR)?

CFR 820.184 requires manufacturers to “establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR).” 

The DHR includes a variety of mission-critical components, including manufacturing date, production number, and more. This allows manufacturers and auditors to easily pinpoint major product deviations. Additionally, the DHR facilitates improved traceability across the entire lifecycle of the medical device.

If you haven’t invested in a quality management system (QMS), trying to build and manage a DHR is an uphill battle. 

Luckily, there’s an easy fix: Qualio’s enterprise-class QMS offers robust document management features designed to make document creation, organization, and editing a breeze. Hundreds of industry-leading quality professionals rely on the Qualio electronic quality management system (eQMS) to manage their DHR and produce high-quality health outcomes for patients around the world.

Up next, we’ll explore some of the core components of a compliant DHR.

Components of a Compliant Device History Record

Manufacturers must submit their DHR to secure pre-market approval. The FDA requires medical device companies to include the following components within the DHR:

  • Manufacturing date
  • Manufacturing quantity
  • Distribution date
  • Testing documentation
  • Labeling documentation

For a complete list of the items required within the DHR, please refer to CFR 820.184.

RELATED READING: What is the FDA 21 CFR? Requirements Overview

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How is the Device History Record Used?

The DHR is used to establish and maintain quality standards throughout the lifecycle of the medical device. Each batch or lot number should, at minimum, meet the DMR requirements established within CFR 820.

Manufacturers rely on the DHR to assist in CAPA quality processes, improve product design, and streamline quality assurance. Without a properly documented medical device, it’s virtually impossible to diagnose the root cause of the nonconformity and activate the appropriate response needed to correct and prevent it.

The DHR also helps medical device manufacturers unlock significant savings. For example, if the manufacturer experiences a product recall, instead of needing to eliminate all products from the market, manufacturers can easily identify the affected batch or lot.

RELATED READING: The 12 Essentials of Quality Management in Laboratory Environments

Maximize the Effectiveness of Your Device History Record with a Quality Management System

The DHR places massive emphasis on documentation and its impact on the quality systems and processes within your medical device company. As such, your DHR is a living and breathing document that requires routine maintenance.

If you’re struggling to manage your DHR, investing in a modern QMS might be exactly what you need. Our feature-rich eQMS comes with powerful document management designed to make document procurement, organization, and collaboration easy!

 

Thousands of quality professionals trust Qualio’s eQMS to transform their quality management and control activities. And you don’t have to go it alone, either. Our onboarding team is standing by from the outset to help your team master system adoption and activation.

If quality is not where it should be at your medical device company, we recommend downloading our free guide: 9 Ways to Improve Quality in Medical Device Product Development.

After downloading it, you’ll have access to some amazing tips to help you immediately improve the overall quality of your medical device during product development.

Check out the guide today and learn how to turn quality into a competitive advantage!

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Published by Ezra Kelderman August 31, 2021