QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

QPharmaBrendan Middleton, 973-656-0011, Ex. 2112Director of Marketing and Public Relations

On Friday, September 20, the final Unique Device Identification (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement.

“In general, industry participants at the conference seemed pleased that their feedback regarding the draft rule was heard and considered by FDA,” noted Beatty.

In publishing the rule, which concerns the establishment of unique identifiers on medical device labeling, FDA introduced a number of key amendments to early drafts:

“With the highly anticipated release of the final rule, medical device companies must prepare to meet the many challenging compliance dates that have been set forth,” said Beatty. “Getting the right UDI on the right product at the right time is a complex and vital function, and we urge all device manufacturers not to delay in establishing their UDI compliance programs.”

For information about QDevice’s UDI compliance services, visit .

QPharma provides a suite of services and solutions to the life sciences industry. Services offered by the company’s Professional Services division include complete validation services, project management, auditing, and training. The Commercial Services division provides solutions in such areas as aggregate spend reporting, PDMA compliance, online training, warehousing and fulfillment, and brand marketing and sales support. The company’s engineers, regulatory compliance experts, and brand consultants have been proudly serving the life sciences industry since 1994. To learn more, visit .

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