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3rd Semi-Annual Medical Device and Diagnostic Labeling Conference



 
Our Price: $495.00

Product Code: 2288
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About the Product
Includes presentation materials from the conference. Presentations slides are in PDF. format. All files are available for immediate download.


About the 3rd Semi-Annual Medical Device and Diagnostic Labeling Conference:

Maximizing Corporate UDI Strategies, Optimizing Label Translation & Content Localization Strategies all while Streamlining Label Approval Operations & Minimizing Human Errors

With the large variety of device and diagnostics on the market, and the ongoing development of new products every year, patients and healthcare professionals need to clearly understand how to handle and utilize medical products safely. This crucial information is conveyed through labels and instructions for use that must respond to an increasing number of complex rules. Labels also serve to enable health authorities, manufacturers and professionals to track products throughout the entire product life-cycle. Ultimately, enhanced traceability facilitates timely post-market surveillance and product recalls, as well as assists in the fight against global medical product counterfeiting. With the release of the FDA UDI rule in 2013, device and diagnostic corporations have had to overcome the challenge of developing new strategies to include this feature in labels, along with implementing the technology that UDI involves. While certain classes of products have reached UDI compliance dates, others are still in the process of building internal processes.

An area of ongoing challenge for labeling executives is also the management of efficient, timely and cost-friendly translation projects. Labels must comprise up to 36 languages, and standards in medical terminology, label content and delivery means differ greatly from one country to another.

A large number of teams within the corporation are involved in the development and collection of critical information that will be utilized to create the label and IfU, Each team involved must have a perfect understanding of the impact of an error in this sensitive data, and internal label approval processes are often lengthy and tedious to ensure no human error is overseen. Furthermore, device and diagnostic labeling and regulatory teams are continuously looking for means of enhancing label compliance strategies in order to ensure the high standards set by health regulators in the United States as well as in international markets are met. Labels must comprise a large number of data and it is of the utmost importance that differing international requirements are perfectly understood to ensure compliance.


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