1WorldSync is actively empowering manufacturers to capture and aggregate data across multiple countries and markets to support their compliance with medical device regulations throughout the global supply chain.
Lawrenceville, NJ (PRWEB) September 08, 2014
1WorldSync announces its Global Data Synchronization Network (GDSN®) standards and Unique Device Identification (UDI) solution has been selected by bioMérieux, a world leader in the field of in vitro diagnostics, to best provide the U.S. Food and Drug Administration (FDA) with reliable and relevant product information. bioMérieux has a presence in more than 150 countries and will deploy 1WorldSync’s GDSN certified data pool in order to efficiently share all relevant product data in compliance with local regulations and customer expectations globally.
The regulation requires most medical devices that are registered in the United States 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 to more accurately identify and trace each medical device. 1WorldSync provides bioMérieux a trusted solution to distribute over a single connection to best meet the regulatory mandates and support the UDI requirements passed by the FDA. 1WorldSync’s GDSN certified data pool will enable bioMérieux to provide the FDA as well as global healthcare customers with complete, reliable and trusted product information that will support the ability to meet compliance challenges and limit costs associated to the UDI regulation.
1WorldSync is working closely with the FDA in providing standard base solution for the healthcare industry. Klaus Schmid, Executive Vice President & Managing Director Europe for 1WorldSync stated, "With the 1WorldSync UDI solution we are able to provide our customers with a simple, automated capability to capture, manage and share comprehensive and accurate product information. 1WorldSync is actively empowering manufacturers to capture and aggregate data across multiple countries and markets to support their compliance with medical device regulations throughout the global supply chain, including International Medical Device Regulatory Forum (IMDRF)."
With more than 15,000 customers across 54 countries, 1WorldSync is the leading product information network and data pool solutions provider, certified within GS1 Global Data Synchronization Network™ (GDSN®). 1WorldSync solutions and services enable businesses to exchange product information across their buy and sell side trading partner communities, via a single cloud based platform – with solutions including Supply Chain Enablement, Product Risk & Compliance, and Omni-Channel Commerce. 1WorldSync is jointly owned by the member organizations of GS1 Germany and GS1 US. GS1 is the preeminent organization for the development of global standards, for identifying, capturing and sharing product information.