Tag Archives: UDI

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!

UDI for 2018: Why You Should Start Now!

September 24th, 2018 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 Labelers:

  1. Understanding the complexities of the UDI legislation as it applies to your organization’s products.
  2. Finding the existing data, creating data that does not exist, and organizing the data into a single point of truth for submission to the FDA GUDID.
  3. Setting up the proper data governance to ensure that the information is correct to meet the deadline and continues to stay up-to-date and accurate in the future.

How 1WorldSync Can Help You

  1. Understanding Rules – Our experts are well versed in the UDI legislation, definitions, and terminology to be able to help your organization identify attributes relevant for UDI per the legislation. Watch our latest and greatest UDI Video to see how we can set you up for success!
  2. Data Collection – Our organization has vast experience with previous UDI customers and can provide education and guidance around attribution. In addition, we can also leverage previous knowledge to directionally aid in the sourcing of attribution. Read our new case study to learn how Teleflex partnered with us to implement a data management solution to comply with the upcoming UDI regulation.
  3. Data Governance – Our team can provide the structure necessary to ensure that information stays up-to-date and accurate, integrating the data collection into day-to-day processes and reducing effort in the future.

Getting To Good Data in the GUDID With 1WorldSync

The general structure of a UDI project is very similar to a typical supplier implementation, with some key exceptions. At the end of the day, data needs to be sent by the supplier to a recipient. 1WorldSync handles this use case on a daily basis and we can provide insight as to proven best practices and strategies.

There are key differences in a UDI project that our experts are trained to guide you through. These key differences include applying for a GUDID account, testing with the FDA, and understanding FDA specific attribution.

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.

Generating Value Beyond Compliance with 1WorldSync

The amount of time and effort to prepare for compliance with the FDA UDI regulation is frequently underestimated. Your organization may need to start sooner than you think.

If you’re like us, you like to be ahead of the game. 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.

Make plans to stop by 1WorldSync (Booth # 6) 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!

For more information around our offerings and experience, please contact us at healthcare@1worldsync.com or visit http://solutions.1worldsync.com/-unique-device-identification.

Are you ready for UDI compliance?

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
  • Audience: Supply Chain, Data Quality and Regulatory Affairs managers
Register today

 

These workshops are free and seats are limited:

United Kingdom

Date and Time: 23rd June 2016, 10:00 a.m. to 12:30 p.m.
Location: Leicester Marriott Hotel, Smith Way, Grove Park, Enderby, Leicester, LE19 1SW UK
Register now

Germany (this workshop is held in German)

Date and Time: 23.06.2016 10:00 – 13:00 Uhr
Location: Tuttlinger Hallen – Tagungsraum 1,
Am Europaplatz – Königstraße 39, 78532 Tuttlingen
Register now

France (this workshop is held in French)

Date and Time : 28.6.2016, de 9h30 à 12h00
Location: Centre Regus Opéra, 27 avenue de l’Opéra, 75001 Paris
Register now

Are You Ready For FDA UDI Compliance?

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 data.

The FDA has mandated an effort to improve the identification of medical devices such as blood glucose monitors to scalpels, which is expected to increase standardization, efficiency and most importantly, safety of patients. But, it does place an additional regulatory burden on device manufacturers.

Are you 100% confident that you’re ready for UDI compliance?

Take Our Interactive Assessment!

We Can Help! 1WorldSync Supports Compliance With FDA UDI Regulation
Leverage our experience and world-class solutions to save resources and quickly amplify your profitability. Our connection to the FDA Global Unique Device Identifier Database (GUDID) means that you’ll have trusted, accurate product information to comply with the UDI regulation.
WorldSync’s healthcare offering is a comprehensive solution to capture, manage and share your product information. Our solution empowers manufacturers to:

  • PREPARE product information to be compliant to FDA UDI regulations
  • CAPTURE and aggregate data across multiple countries and markets to ensure compliance with medical device regulations throughout the global supply chain, including International Medical Device Regulatory Forum (IMDRF)
  • MANAGE product information from multiple entry points to ensure complete and accurate information.
  • DISTRIBUTE product information using a timely, manageable and auditable methodology.

Talk To An Expert Today!

Have you started planning for UDI compliance?

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 compliance product information to the FDA?

Join the ranks of leading medical device manufacturers that are leveraging 1WorldSync to implement product information strategies for UDI compliance and beyond. Want to learn more?

Attend our informative webinar, How to Turn UDI into a Competitive Advantage, hosted by 1WorldSync Healthcare Industry Expert Todd Simons and Nada Savatic of Abbott Laboratories. Ready to get started today? Sign up for the 1WorldSync UDI solution or come visit us at Booth #6 at the FDA UDI Conference April 18-19 in Baltimore, MD.

Streamlining the Global Healthcare Data Supply Chain to Comply with Safety and Traceability Mandates

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 to make informed decisions about their health, care and wellness.

Continue reading

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

Regulatory Compliance and Beyond

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 world are being driven by local, federal, and global regulations to streamline their product information distribution systems for accuracy and transparency. Its impacting multiple industries; EU1169 in the foodservice and FMCG/CPG industry, UDI in the Healthcare industry, GHS in the DIY/Hardlines industry. Organizations are being compelled to act and in the process of assessing the scope and impact, are seizing the opportunity to achieve additional benefits.

Global organizations are seeing that readying product information for regulatory compliance comes with valuable byproducts. As internal systems are evaluated and streamlined to achieve compliance, additional business benefits are being achieved; supply chains are becoming optimized for efficiency, processes for data quality and accuracy are being implemented, and e-comm initiatives are being powered and supported. Product information is becoming rich, robust, accurate and readily available to customers and consumers alike, and businesses are becoming more efficient, compliant, and transparent.

Mondelez International is a shining example of how readying product information for regulatory compliance can transform systems and enable trusted, transparent product information exchange. Their approach of implementing a single global solution across all markets not only prepared their data for EU1169 compliance, but empowered their business for critical omni-channel initiatives. Read more about how Mondelez International met their regulatory deadline and then some!