Tag Archives: medical devices

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, 2018.  This has made medical device manufacturers on a global basis, readying their organizations for compliance. As a leading healthcare provider or manufacturer, do you find yourself asking yourself the following questions?

  • What is the scope of products impacted (exempted or not)?
  • What are my obligations under FDA UDI regulation?
  • How do I transform compliance into a competitive advantage?
  • How can I source my data from multiple locations, formats and systems, controlled by different functions?
  • How can I ensure the data I provide to the FDA is complete and accurate?

1WorldSync & Innovit Join Forces

Innovit,  a global provider of software solutions for PIM (Product Information Management), MDM (Master Data Management), GDSN (Global Data Synchronization) and Enterprise Workflow Management, and 1WorldSync™, the leading provider of product content solutions, possess a collaborative agreement to enable more robust product content capabilities for the medical device industry.

Whilst manual data entry or Excel spreadsheet upload may have been a viable solution for Class II & III submission deadlines, Class I poses a much greater challenge for labelers.  The sheer volume of products in this category makes manual submission methods too slow.  High product volume increases the burden of data collection, data cleansing and data entry to the GUDID.  The risk of failing to meet FDA’s deadline increases substantially.  

Innovit’s ‘UDI Multi-Connector’ is an automated, machine-to-machine data validation and submission system designed to address today’s needs for GUDID, as well as tomorrow’s needs for other global UDI recipients such as EUDAMED, NHS, and more.    

Whether your organization relies on a HIBC or a GTIN (or you’re looking for definitions on what those terms mean), 1WorldSync offers multiple solutions to send your data to the FDA. A primary benefit of submitting data through a 1WorldSync solution is that the data collected can be easily sent to other recipients, including GPOs, distributors, and other healthcare providers.

With the 1WorldSync UDI Solution, your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.

One Process, One System and One-time Investment for Compliance. Advanced Readiness

Get ahead of the game and get back the time to focus on producing quality products your customers and patients love! For organizations manufacturing medical devices, 1WorldSync & Innovit experts can help organization prepare to meet the September 24, 2018 deadline through our comprehensive solutions.

Manufacturers can create a sustainable process to collect, manage, and distribute product content to all their UDI recipients, including FDA GUDID, EUDAMED, NHS, and others.

Make plans to visit Innovit and 1WorldSync at the UDI Conference taking place June 7-8 in Baltimore. Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID from our experts first-hand!

*GUDID – Global Unique Device Identification Database

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 1WorldSync with Reed Tech medical device product data management solutions, the two organizations together are able to offer device manufacturers a single full-service approach to device product data management.

“This collaboration will allow the medical device industry to receive expanded, customizable offerings to meet current and future challenges,” said Dan Wilkinson, Chief Commercial Officer at 1WorldSync. “Our agreement benefits customers of both companies, enabling more robust product content support to meet the continually changing mandates and regulations in healthcare.”

Ethan Eisner, VP of Global Commercial Markets at Reed Tech, also indicated his enthusiasm for the project. “Reed Tech is a leader for medical device product data management solutions, including Unique Device Identifier (UDI) regulatory filings to the FDA. Our organizations are well-aligned to offer superior value to our customers through a single solution capitalizing on the strengths and expertise of both companies. We are excited about the addition of GDSN capabilities into our medical device data management solutions.”

Generating Value Beyond Compliance

With a single, full-service solution from 1WorldSync and Reed Tech, you can feel confident in your company’s product content and rededicate your time to producing the quality products your customers and patients need.

1WorldSync and Reed Tech can help your organization manage and capitalize on the value of your product content, syndicating to trading partners to fulfill requirements of governmental authorities (such as FDA UDI and UK NHS eProcurement) and buyers (such as GPOs and influential hospital networks).

Visit 1WorldSync (booth #6) and Reed Tech (booth #20) at the UDI Conference in Baltimore June 7-8. Learn UDI implementation strategies and identify a sustainable process to successfully manage your device product content from our experts first-hand!

On May 23, Reed Tech and 1WorldSync will co-present a free webinar for industry members on how to meet the UK NHS eProcurement deadline and provide product data to buyers. Register now!

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