Tag Archives: UDI

Annual Congress 2014 Cologne

1WorldSync Annual Congress – Stay Connected!

One of my favorite events at 1WorldSync is the Annual Congress in Cologne, Germany. Last year, I was impressed by the variety of topics and in-depth individual sessions. Annual Congress provides insights on how having accurate product information can open many doors for your company.

1WorldSync’s Annual Congress which will be held on September 30 – October 1, 2014 provides a platform to inform, share and listen to customers and partners and provide holistic answers to questions that arise from increasing industry challenges. It’s an exciting two days of collaboration, so get ready!
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I’m not sure what UDI stands for, how will my Organization be ready for compliance?

A recent United States Food and Drug Administration (FDA) regulation, issued on September 24, 2014 has medical device manufacturers on a global basis, readying their organizations for compliance. The new regulation requires most medical devices to be marked and labeled with a unique device identifier (UDI) and then entered into the FDA’s Global Unique Device Identification Database (GUDID) with a set of FDA-specified attributes.  Compliance dates are driven by the class of medical device. Continue reading

Addressing Continuous Product Safety & Compliance – Cope is not a Strategy!

How does your business address product risk and compliance?    Are you simply coping from one regulatory mandate to the next… stringing several point solutions together as you go along, or is there a more holistic solution.   For most businesses, addressing product risk and compliance is not an easy one to answer and you are certainly not alone.  Collecting, storing, managing and validating product safety or risk-related information is not a simple undertaking.  Whether you are a medical device manufacturer preparing to comply with the upcoming FDA UDI regulations, a Foodservice brand owner selling your products in Europe enforced to comply with EU Food regulations (e.g. EU 1169 ) or a retailer facing demands for accurate, robust and legally compliant product information from consumers. The ability to control quality data and its distribution across a large network of external trading partners becomes an ever growing challenge.  With legal and regulatory drivers behind these needs, failure to manage product risk effectively is not an option, and can have a major impact upon your sales and brand. Continue reading