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Postmarket

Medical Device Reporting (MDR) Software

Medical device reporting (MDR) is complex. But it’s essential for compliance. MDR software streamlines compliance processes.

Medical device makers must disclose product problems and adverse events to regulators. Without a robust MDR solution, these reporting practices are inefficient and prone to error. MasterControl’s MDR system digitizes reporting processes. Our electronic MDR (eMDR) software is designed to optimize MDR quality and compliance.

MasterControl eMDR™
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There’s an easier way to manage medical device reporting.

01

Digitized MDR Processes

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MasterControl streamlines electronic medical device reporting. Our eMDR software facilitates the timely collection and submission of MDR data. The advanced MDR system lets you submit reports electronically, which saves time and resources. 

02

Thorough MDR Documentation

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Reportable event information can easily slip through the cracks. MasterControl eMDR software ensures all MDR files are documented and accessible in a centralized, secure system. 

03

Best-Practice Forms

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MasterControl can electronically populate MDR forms like MedWatch Form 3500A. The MDR system also auto-routes forms to preselected viewers and approvers. The eMDR software’s built-in MDR forms include drop-down menus that make it easy to select common information and enter data quickly and accurately. The standard form design simplifies printing and offers users a familiar interface.

04

Connected Quality

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The impact of a quality event goes far beyond medical device reporting. That’s why our eMDR software tightly integrates MDR with all core quality processes. With the connected MasterControl MDR system, event data can be set to automatically fill fields on corresponding forms.

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Medical Devices in hospital

Complete MDR Quality Management

Competition is fierce in the medical device industry. You need more than just an MDR quality management system. MasterControl unifies MDR activities with your overall approach to medical device quality management. Our solutions are designed to connect data across the entire product life cycle. 

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Robust Reporting Capabilities

MasterControl’s eMDR system creates summaries that provide the most relevant data for all MDRs. It also presents the most relevant data for MDRs awaiting acknowledgements. Configurable standard reports are included in the eMDR software. Users can group MDRs by product or outcome type and generate totals and charts. 

Prevent MDR headaches.

eMDR software is the key to reporting efficiency.

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