Medical Device Reporting Services

Save time by authorizing Qualomics to prepare

and submit electronic medical device reports for you.

Our Process

Delegate

Authorize Qualomics to submit eMDRs on your behalf.

Notify

Notify Qualomics when there is a reportable event.

Report

We prepare and submit the report to FDA for you.

Z

Confirm

We receive and file the records and receipts.

GET STARTED

Outsource Your eMDR Submissions with Confidence

Your Journey to Easy FDA Compliance Starts Here

Submitting medical device reports (MDRs) to the FDA’s MAUDE database is a required, but often burdensome, task for manufacturers. Setting up electronic reporting, managing submissions, and ensuring ongoing compliance can take valuable time and internal resources.

That’s where Qualomics comes in.

We are authorized to submit electronic medical device reports (eMDRs) on your behalf so you don’t have to manage the process alone.

What We Handle for You

    • Electronic report submissions through the FDA’s ESG NextGen gateway

    • Ongoing reporting of adverse events, malfunctions, and other MDRs

    • Support for both domestic and foreign manufacturers

    • Compliance with 21 CFR Part 803 reporting requirements

    • Timely, audit-ready documentation of all submissions

Why Outsource Your eMDRs to Qualomics

    • No need to manage a complex FDA submission system
    • Avoid costly delays or errors in required reports
    • Stay compliant without hiring or training internal staff
    • Gain peace of mind with expert guidance and oversight

What types of events must be reported?

Mandatory reporting is required:

    • If any medical device has caused or contributed to a death or serious injury.
    • Malfunctions are likely to cause or contribute to death or serious injury if they recur.

FDA describes both voluntary and mandatory reporting rules in 21 CFR 803.

We can prepare and submit Form 3500 for voluntary reports or Form 3500A for mandatory reports.

Can someone submit an eMDR on my behalf?

Yes. Manufacturers can submit eMDRs directly to the FDA, or authorize a partner like Qualomics to submit on their behalf. We are already registered with the FDA’s ESG NextGen gateway and ready to submit right away, while a firm setting up on its own would first need to register its own account and complete a test submission before it could report.

To get started, we provide a template Letter of Authorization that names Qualomics as your authorized submitter. Once it is in place, we prepare your FDA Form 3500A reports and submit your eMDRs for you, with audit-ready documentation of every submission.

Frequently Asked Questions

What is a reportable event?

A reportable event can refer to any unfavorable occurrence involving your medical device in the market. However, mandatory reports are required by FDA if a medical device has:

  • Caused or contributed to a death or serious injury
  • Malfunctioned and could potentially cause or contribute to a death or serious injury if the malfunction were to recur

However, many companies use a slightly less strict definition of reportable event, and will instead choose to report events where the patient sought medical care.

FDA Regulation 21 CFR Part 803 specifies the types of reports and data that must be included in each eMDR submission.

Once received, the FDA Center for Devices and Radiological Health (CDRH) will process, review, and publish your eMDR.

Do I need to submit a medical device report to FDA?

Medical device manufacturers must report adverse events to the FDA, and failure to do so can result in financial penalties and, in serious cases, criminal prosecution. The FDA uses these reports to monitor the safety and performance of medical devices and to take action when necessary to protect public health.

It is important for manufacturers to understand the reporting requirements and to have a process in place for the timely and accurate reporting of reportable events, as this is one of the things FDA inspectors will expect. 

Since 2015, these reports must be submitted electronically through the FDA’s electronic submissions gateway, now known as ESG NextGen. Once a report is accepted, it becomes part of the public MAUDE database.

Qualomics maintains an active ESG NextGen account and can prepare and submit your eMDR quickly and accurately.

What if I want to open my own ESG NextGen account?

The FDA’s newer ESG NextGen system has made this process much simpler than the previous version, most notably by doing away with the personal digital certificate that submitters once had to obtain.

To register with the FDA’s Electronic Submissions Gateway, now ESG NextGen, and begin submitting MDRs, follow these steps:

  1. Create an ESG NextGen account through the FDA’s Unified Submission Portal, using your email and password.
  2. Provide a Letter of Non-Repudiation during registration. You can upload a signed copy or create and sign one electronically in the registration wizard.
  3. Prepare and submit a test eMDR (a mock report, not an actual adverse event report) containing the information specified in the appropriate section of 21 CFR Part 803: 803.32 for user facilities, 803.42 for importers, or 803.52 for manufacturers.
  4. After your test submission is accepted, you can begin submitting your actual eMDRs to the FDA