Aug 17, 2021 Ezra Kelderman

What is the Device Master Record (DMR)?

The 21 CFR 820.181 regulation requires all medical device manufacturers to maintain concrete records related to device specifications, quality assurance procedures, and more.

Unfortunately, it’s a requirement that many medical device startups and scale-ups overlook — especially during the early phases of growth. 

Without the device master record (DMR), reviewing and maintaining device performance becomes incredibly difficult.

And without an electronic quality management system (eQMS) to store the DMR, medical device performance review and management are virtually impossible.

If you’re preparing to build a DMR or reevaluating an existing DMR, we’ve created a simple resource to help you set off on the right foot.

Keep reading to learn more about the components of an effective DMR.

Overview: What is a Device Master Record?

When it boils down to it, investing in a quality management system (QMS) is the single most important thing you can do to ensure the safekeeping of your device master record — as well as your design history files and device history records, for that matter.

A well-designed QMS should come equipped with powerful document control features like document indexing, document query, user permissions, and more.

Qualio is the first cloud-based QMS purpose-built for medical device manufacturers. Our system comes backed with the latest document management features you need to appropriately store, organize, and disseminate important documentation.

As manufacturing processes and design inputs change inside the DMR, manufacturers can easily apply and reference updates inside of the QMS. This kind of file organization and management comes in useful during unforeseen audits.

Elements of the Device Master Record

Rule 21 CFR 820.181 states that “each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.420.” 

The U.S. Food and Drug Administration (FDA) goes on to recommend the following elements of the DMR:

  • Device Specifications
  • Production Product Specifications
  • Quality Assurance Procedures and Specifications
  • Packaging and Labeling Specifications

Each section of the DMR should be properly labeled, neatly organized, and accessible to your team members, as well as FDA regulators. A QMS facilitates total file organization and accessibility across both internal and external ecosystems, making the process much easier.

RELATED READING: 5 Amazing Medical Device Document Management Tips

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How is the Device Master Record Used?

In addition to audits, the DMR is especially useful when quality issues are detected. 

For example, imagine that a key component of your medical device failed. Without the DMR, finding the source of the issue (e.g., manufacturer or materials used) is kind of like trying to find a needle in a haystack. You’ll end up spending hundreds or thousands of hours hunting down the root cause of the issue.

A DMR makes it simple and easy to access important manufacturing information, including production dates, approval records, batch numbers, and more. 

After careful analysis, you can easily identify the batch or lot affected and deploy the necessary corrective and preventive actions (CAPA) needed to permanently resolve the issue.

RELATED READING: Solving the 4 Most Common Quality Management Issues

How to Find the Right Quality Management System for Your Medical Device Company

Finding the right QMS for your medical device company helps you maintain an effective DMR. From improved file organization to document search, the benefits of a QMS are virtually limitless for teams still using paper-based systems.

Qualio’s eQMS has all the features you need to expedite FDA and ISO compliance. Instead of spending weeks wrapped up in the approval process, Qualio enables your life sciences company to run through each step quickly and efficiently.

 

“Qualio deserves praise for its simplistic and user-friendly interface. We made the right choice by introducing Qualio to our organization. We appreciate how it improved the entire document management process which would have otherwise been a big distraction if not handled correctly. Highly recommended!” — Dragan V., Software Engineer.

How does your organization’s approach to quality management stack up against industry best practices? 

To help you find out, we’ve created this simple self-assessment.

After completing this short quiz, you’ll have all the resources and information you need to immediately improve your quality management procedures. 

Once you’ve finished the test, you’ll also have an opportunity to speak with one of our quality professionals to learn more about your results.

Ready to learn more about the easiest way to strengthen your life science company’s quality stance? Request a demo today.

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Published by Ezra Kelderman August 17, 2021