Medical Device and Diagnostic Labeling Conference
September 24-25, 2015 | San Diego, CA
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ABOUT THE CONFERENCE
The conferences was created as a way to discuss and find solutions for the large variety of devices and diagnostics on the market that require ongoing labeling and tracking as well as the newly developed products every year that patients and healthcare professionals rely on . UDI Compliance is all about satisfying the need to clearly understand how to handle and utilize medical products safely. Proper labeling provides crucial information that can quickly, easily and accurately be conveyed through labels and instructions for use that must respond to an increasing number of complex government mandated rules.
UDI Labeling also enables health authorities, manufacturers and professionals to track products throughout the entire product life-cycle. That capability allows for enhanced traceability, timely post-market surveillance and urgent product recalls, while simultaneously becoming an important safeguard in the fight against global medical product counterfeiting.
The FDA UDI Compliance rules released in 2013 set a new standard for device and diagnostic corporations that now must overcome the challenge of developing strategies to comply with this legally required feature in labels, that has lead to a series of new labeling technologies specific to UDI compliance protocols. Some classes of products have already reached UDI compliance dates and many others are near their activation dates, causing all forward thinking medical device manufacturers and healthcare providers to carefully evaluate their own internal and external labeling process.
Due to the expanse of labeling data under UDI compliance rules, management of efficient, timely and cost-friendly translation projects is becoming an essential element of operating a successful business within medical sector. Labels must include as many as 36 languages, with standards in medical terminology, label content and delivery means differing greatly from one country to another.
Fortunately for many top tier companies, UDI Compliance Solutions is making a turn-key solution available that is completely compliant, simple to implement and efficient at every point along the timeline from today into the future, allowing our clients to focus on their own core competency while shifting the workload of UDI Compliance solutions to a professional team that specializes in this unique aspect of legal labeling compliance for the medical community.This conference is pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion and served an important role in the educational process that allows these UDI Compliance to be fully understood and managed with the greatest level of care.