Tag: GUDID

【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.

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 […]

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 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 […]

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 […]

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 […]

Major Release 3 Pre-Production GUDID Testing Transition Plan

By | February 4th, 2016

Good news for 1WorldSync users who are currently sending test data to the FDA’s Pre-Production GUDID! Major Release 3 testing is scheduled to become available on March 7, 2016.

The FDA wants YOU – to be compliant

By | September 23rd, 2015

September 24th 2015 is upon us, thus the second deadline for UDI compliance has arrived. As a quick recap, the FDA is requiring all medical device product information to be submitted to their Global Unique Device Identification Database (GUDID) in order to more easily and accurately identify and trace medical devices along the supply chain. […]

Transformer le paysage mondial des soins de santé

By | September 18th, 2015

Cet article est paru initialement dans le magazine Supply & Demand Chain Executive le 20 juillet 2015. La publication d’informations produit erronées sur la chaîne d’approvisionnement peut avoir de lourdes conséquences, en particulier dans le secteur de la santé où elles peuvent faire la différence entre le bien-être et la maladie, la vie et la mort. Ces dernières […]