Tag Archives: GUDID

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 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

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

Transformer le paysage mondial des soins de santé

Cet article est paru initialement dans le magazine Supply & Demand Chain Executive le 20 juillet 2015.

La publication d’informations produit erronées sur la chaîne d’approvisionnement peut avoir de lourdes conséquences, en particulier dans le secteur de la santé où elles peuvent faire la différence entre le bien-être et la maladie, la vie et la mort. Ces dernières années, la diffusion d’informations produit défectueuses a eu des répercussions sur la chaîne d’approvisionnement des soins de santé. L’industrie a ainsi dû faire face à des défis significatifs avec pour conséquences une augmentation des coûts de fonctionnement et un impact sur la qualité des soins fournis aux patients.

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.

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