Tag: medical device manufacturers

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 […]

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 […]

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. […]

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 […]

1WorldSync Annual Congress – Stay Connected!

By | July 8th, 2014

One of my favorite events at 1WorldSync is the Annual Congress in Cologne, Germany. Last year, I was impressed by the variety of topics and in-depth individual sessions. Annual Congress provides insights on how having accurate product information can open many doors for your company. 1WorldSync’s Annual Congress which will be held on September 30 […]

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

By | July 7th, 2014

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 […]