Tag: UDI

【実施報告】第四回米国進出セミナー

By | September 28th, 2018

Blog-Image__【実施報告】第四回米国進出セミナー_JP_Sept2018

1WorldSync participated in the “Advance into US market for Medical Device companies” Vol.4 in Tokyo, Japan on September 14 (organized by  Globizz Corp./ sponsored by the US Embassy / 6 sessions in the seminar). There were about 100 attendees at the seminar.

1WorldSync spoke about “Expand Global Business by Corresponding UDI Regulations”. It’s getting more important to control product data initiatively for adopting not only UDI compliance in global but also data requirements from healthcare institutes/GPOs. (Some of hospitals/GPOs in EU are doing pilot to implement GDSN connection.) 1WorldSync has the solution for providing data accurately to meet these requirements and supports Medical Device companies with 1WorldSync single platform.

From UDI to GDSN: How the Medical Device Data Landscape Keeps Evolving

By | July 18th, 2018

Blog-Image__From UDI to GDSN: How the Medical Device Data Landscape Keeps Evolving_EN_Jul2018

Are you receiving requests for  your product data from large GPO’s and hospital networks? Medical device manufacturers receiving these requests from buyers, often require a unique dataset to be transmitted to them by the manufacturer through the Global Data Synchronization Network (GDSN) for each product available for purchase. These companies require unique, but overlapping, datasets […]

The Arthrex Journey: Achieving Data Requirements For UDI And Beyond

By | May 2nd, 2018

The next UDI Compliance deadline for Class 1 is September 24, 2020.  We want to make sure you are prepared to meet those requirements and evaluate the breadth of products that impact your company. Many medical device manufacturers, including Arthrex, have already had to prepare for FDA’s UDI and meet compliance dates for Class III […]

A Joint Solution: Manage & Syndicate Medical Device Product Data with Reed Tech and 1WorldSync

By | December 7th, 2017

Medical device professionals face an ever-growing list of demands for their product data from downstream users all over the world. Some of these demands are regulatory, such as FDA’s Unique Device Identification (UDI) submission mandate. Others are commercial, such as hospital networks needing access to device product data electronically through the Global Data Synchronization Network […]

1 Solution – Global Healthcare Compliance

By | July 10th, 2017

The healthcare industry is evolving and the ability to control trusted quality data can be challenging. If you manufacture or supply medical devices or pharmaceuticals, then you’ll need to comply with multiple regulations in the near future. Whether it’s for the public sector (NHS in the UK), Group Purchasing Organizations, Regulation in Europe (MDR and IVDR) or […]

Lights, Camera, Action: 1WorldSync AUG 2017 Awaits!

By | June 8th, 2017

We hope that you are as excited as we are about the 1WorldSync 2017 Annual User Group, Americas co-located with GS1 Connect, June 19th & 20th taking place in Las Vegas! With a couple weeks to spare before this highly anticipated event, 1WorldSync is busy rolling out the green carpet for you. It’s officially the era of […]

UDI: Generating Value Beyond Compliance

By | May 9th, 2017

UDI: Generating Value Beyond Compliance

Getting to Good Data in the GUDID* The United States Food and Drug Administration (FDA) regulation mandates that UDI data for Class I medical devices to be submitted with an impending deadline of September 24, 2020.  This has made medical device manufacturers on a global basis, readying their organizations for compliance. As a leading healthcare […]

UDI for 2020: Why You Should Start Now!

By | May 8th, 2017

September 24th, 2020 for Class I UDI compliance is just a heartbeat away, particularly when evaluating the scope of the UDI initiative and the breadth of products impacting your company. Many suppliers that have previously submitted Class III and Class II product data have already begun gathering and sending Class I data. Key Challenges for UDI […]

UDI: One Cost for Compliance. Advanced Readiness

By | May 8th, 2017

UDI: One Cost for Compliance. Advanced Readiness

1WorldSync, the leading provider of product content solutions, recently entered into a collaborative agreement with ReedTech, a provider of data management and analytics solutions for the life sciences industry, to enable more robust product content solutions for the medical device industry. 1WorldSync™ & Reed Tech® Join Forces Through the integration of data exchange capabilities from […]

Are you ready for UDI compliance?

By | June 14th, 2016

This free workshop provides insight for how your business can comply with the FDA UDI regulation. You will learn about: how to transform compliance into a competitive advantage? what are your obligations under the FDA UDI regulation (Class I and Class II products)? how leading manufacturers successfully use 1WorldSync solutions to efficiently manage those challenges […]