Tag Archives: Global Unique Device Identification Database

The FDA wants YOU – to be compliant

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. (You can find out more about the regulation and compliance deadlines here.) Continue reading

The Power of 1WorldSync Product Information Cloud

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 the cloud?
  • Understanding the power and presence of data?

It is a new frontier, a ‘Data Revolution’, and the healthcare industry, specifically, is on the proverbial cliff ready to jump in head first. With the ongoing transformation of the U.S. healthcare delivery system, supply chain has become a key component to meeting organizational goals by driving clinical value, implementing innovation, and delivering operational efficiency. In order to fulfil its multifaceted objectives, supply chain is engaging with various stakeholders in pursuit of a common mission to foster a coordinated healthcare delivery system. Specifically, the impact of the ‘Data Revolution’ and the ‘Big Data’ explosion on the healthcare industry has spurred the creation of governmental and regulatory mandates, such as the Unique Device Identification (UDI) regulation set forth by the FDA. The UDI regulation require all medical device manufacturers to publish complete and accurate product information to the Global UDI Database (GUDID). To comply with the regulation, all medical device manufacturers must publish all required medical device product attributes to the GUDID by the specified time or face strong consequences.

Whether it’s in the form of regulatory compliance, seamless deployment along the supply chain, expanded storage, or collaborative networks or solutions, companies and businesses are looking to improve their top and bottom lines, and trusted product information is proving itself as a time and cost saver with the ability to help businesses grow. This is the core of 1WorldSync services and solutions. By building genuine business relationships and developing detailed strategic solutions 1WorldSync services address the most critical challenges within organizations in support of supply chain efficiency and regulatory compliance.

Join 1WorldSync at AHRMM15 to explore key ideas, trends, and best practices around building strategic stakeholder engagement, with an emphasis on supply chain perspective. Visit 1WorldSync at booth 924 and learn how the leaders in data pool management solutions and services can support your business for trusted product information exchange.

We look forward to seeing you there!

 

OUR Mission:

To be the Healthcare industry leader in product information exchange and the change agent that drives the industry forward through global regulatory compliance and improving healthcare standards.

Shifting paradigm in healthcare

1WorldSync had the great pleasure of attending the Annual AHRMM Conference August 3-6, 2014. There was a lot of valuable information shared, but above all, it was clear that the Healthcare Industry is well on its way to realizing the benefits of GS1 Standards and eventually, the GDSN.

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I’m not sure what UDI stands for, how will my Organization be ready for compliance?

A recent United States Food and Drug Administration (FDA) regulation, issued on September 24, 2014 has medical device manufacturers on a global basis, readying their organizations for compliance. The new regulation requires most medical devices 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.  Compliance dates are driven by the class of medical device. Continue reading