Global Unveiling of UDI Connect App at UDI Conference

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UDI Connect is an application that enables medical device companies and healthcare providers to better identify and track medical devices.

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USDM is responding to the needs of the medical device industry by offering a mobile solution that not only meets regulatory requirements but also creates more efficient business processes.

USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce the release of its newest app, USDM UDI Connect.

UDI Connect is an application that enables medical device companies and healthcare providers to better identify and track medical devices, ensure patient safety, improve operational effectiveness and provide global capability to identify any FDA registered medical device.

“USDM is responding to the needs of the medical device industry by offering a mobile solution that not only meets regulatory requirements but also creates more efficient business processes,” said Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences.

By scanning a medical device’s Unique Device Identifier (UDI) barcode with a smart phone or tablet, the UDI Connect App provides on-demand access to all the data attributes stored in FDA’s Global UDI Database (GUDID). UDI Connect includes an option to add access to proprietary data. Users can instantly retrieve essential information about a medical device to support a host of business and patient safety uses.

UDI Connect Uses Include:

  •     Consignment Inventory
  •     Trunk Stock (Sample) Tracking
  •     Documentation of Device Use and Implantation
  •     Requests for Additional Information
  •     Complaint Management
  •     Recall Management

See Demonstration of UDI Connect at UDI Conference

  •     When: June 24 & 25, 2015
  •     Where: Hilton Baltimore in Baltimore, MD
  •     Booth: #6

Join our Session on Thursday

  •     The Challenges and Opportunities of UDI Implementation
  •     Thursday, June 25 at 3:45pm

Jay Crowley will discuss how the successful and efficient implementation of UDI requires understanding of how your organization currently manages device identification and distribution and how it may mean modifying some parts of your infrastructure.

Jay Crowley is the Vice President of Unique Device Identification Solutions and Services at USDM Life Sciences.

Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s UDI system.

About USDM Life Sciences:
USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services via project teams and staff augmentation to our clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. USDM Life Sciences has more than 15 years of experience supplying our clients in the life science industry with compliance services during each phase of their drug and product development cycle while partnering with best of breed organizations to help companies simplify, unify and optimize their business and compliance objectives. For more information, please visit http://www.usdm.com.

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Ryan Carmel
USDM Life Sciences
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