Tag: 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 […]

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 […]

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. […]

Regulatory Compliance and Beyond

By | August 21st, 2015

Globally, businesses are experiencing the same challenge: they need robust, trusted, accurate product information. Consumers are demanding it, trading partners are requiring it, and governments are mandating it. While meeting consumer and customer demands are certainly a driver for change, regulatory mandates with tangible repercussions for non-compliance push businesses into action. Organizations all over the […]

The Power of 1WorldSync Product Information Cloud

By | August 10th, 2015

As an avid reader of Bloomberg Businessweek, I was excited to see cloud technology, code, data management, everything that we, 1WorldSync, live and breathe, dominating the June 2015 issue. It got me thinking, how do we as a world, as an industry, as a business, educate decision makers on: ‘Understanding and unlocking’ the value of […]

Transforming the Global Healthcare Landscape

By | July 23rd, 2015

Blog originally featured in Supply & Demand Chain Executive business magazine on July 20, 2015. The effects of inaccurate product information across the supply chain are tremendous, particularly in the healthcare industry where its implications can mean the difference between wellness and illness, life and death. In recent years, the impact of flawed product information ricocheted […]