QPharma’s Medical Device Division Advises Manufacturers to Prepare for UDI Compliance
QDevice, the medical device consulting division of QPharma, is advising its clients and all medical device manufacturers to prepare for compliance with the Unique Device Identification (UDI) final rule, which is expected to be passed this year. The company is holding an educational seminar on UDI readiness on Monday, September 9 in Morristown, New Jersey.
UDI will require medical device makers to place a unique numeric or alphanumeric code on every device or label, which will include such information as batch number, serial number, and/or expiration date. The Food and Drug Administration (FDA) anticipates that the regulation will enable improved patient safety and quicker identification of product problems.
“Our QDevice division offers a wide variety of solutions to help device manufacturers prepare for UDI compliance,” said Tom Beatty, who serves as QDevice’s Senior Principal, UDI Compliance. “Whether our clients need training, assessments and analysis, or validation of systems and processes, we’ve got them covered. We are advising all medical device companies to educate themselves on the requirements of the proposed rule. The time to prepare is now.”
On Monday, September 9, a three-hour educational seminar on UDI preparedness will be held at the Hyatt at Headquarters Plaza in Morristown. The $99-per-attendee fee will include breakfast and lunch. Participants can register at www.qpharmacorp.com/udi-conference.
Beatty recently delivered a presentation on the topic of UDI compliance at the Center for Business Intelligence’s 9th Annual Medical Device and Diagnostics Compliance Congress in Washington, D.C. His article on the importance of UDI readiness will be featured in an upcoming issue of Medical Device and Diagnostic Industry, and is available for download on the QPharma website at www.qpharmacorp.com/udi.
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