Tag: FDA

【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.

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 […]

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: 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 […]

A Connected Lifestyle for 2017

By | April 6th, 2017

We are all living a Connected Life in 2017. Connected and mobile commerce is a way of life for us all and businesses are striving to leverage this connectivity to improve consumer safety, the customer experience and increased market penetration.   The growth of cross-channel commerce is a core component of every business plan, regardless of […]

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 […]

Are You Ready For FDA UDI Compliance?

By | May 17th, 2016

Take Our Interactive Assessment and Find Out If You’re Prepared to Meet the September, 24th, 2016 Class II UDI Submission Date The deadline for Class II Unique Device Identification (UDI) submissions is September 24, 2016.  With only a few short months remaining, companies are faced with the significant challenge of locating tremendous amounts of product […]

Have you started planning for UDI compliance?

By | April 6th, 2016

Class II and Class I UDI compliance deadlines are rapidly approaching. Does your strategy enable your business for long-term success? As a 1WorldSync customer you can add easily add UDI compliance to your existing subscription. You’re already exchanging trusted, accurate product information with your trading partners – why not use that process to send UDI […]

Streamlining the Global Healthcare Data Supply Chain to Comply with Safety and Traceability Mandates

By | February 22nd, 2016

Article originally featured in Pharmaceutical Compliance Monitor. The demand for robust product information is pervasive. It touches every industry and comes from multiple facets – end consumers to global governments – and the healthcare industry is no exception. Patients are no longer simply recipients of care, but active participants requiring access to rich product information […]