On-Demand Webinar: Global UDI Data Management – The New Paradigm
Preparing and managing your device information for UDI medical device databases globally
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What You'll Learn
- The current state of UDI regulations worldwide and how national UDI databases (US, EU, SFDA, NMPA, KFDA, HSA) are expanding.
- The new device-manufacturer challenge: creating, submitting, and maintaining required data — and regulatory compliance — across multiple national databases over time.
- Why the ability to use and reuse data attributes across databases depends on thorough understanding of required data, accurate mappings, and transformations.
- How emerging UDI (and UDI-like) use cases — commercial, payment, supply chain, and postmarket surveillance such as registries — raise the bar for accurate, timely data.
- How USDM Cloud Assurance for atrify maintains continuous compliance through atrify cloud updates and supports better data management and submission.
About This Webinar
Currently, multiple regulators have or are launching national UDI Databases (US, EU, SFDA, NMPA, KFDA, HSA). Other regulators are following close behind. The new UDI challenge for device manufacturers is creating and submitting the required data to these national databases and maintaining this data – and regulatory compliance – over time.
The ability to use and reuse these data attributes across multiple databases is critical to success. However, this requires a thorough understanding of the required data, accurate mappings, and transformations of the data attributes. Treating UDI as a governed, high-integrity data asset is foundational here — strong data integrity in life sciences practices keep your records consistent and submission-ready across every market.
At the same time, other users and use cases for UDI (or UDI-like) data are emerging – including commercial, payment, supply chain, and postmarket surveillance (e.g., registries). Providing accurate and timely data to these systems is also critical.
To best serve the medical device industry, USDM and atrify have supplemented our UDI services and UDI technology with USDM Cloud Assurance for atrify. This solution efficiently addresses the initial validation and ongoing release management maintenance of your validation to assure continuous compliance through the atrify cloud updates. Anchoring that work to a risk-based computer software assurance (CSA) approach and ongoing USDM Cloud Assurance keeps your validated systems audit-ready as the vendor cloud evolves.
The On-Demand Webinar Discusses
- The state of UDI regulations worldwide
- Technical considerations and guidance for managing UDI Data
- Cloud Assurance for atrify to maintain continuous compliance and support better data management and submission processes
- Q&A
Why this matters: As more regulators stand up national UDI databases, manufacturers face the same device data being collected differently in every market. USDM's point of view is that UDI is a data-management problem first and a submission problem second — get the underlying data attributes, mappings, and transformations right, govern them as a high-integrity asset, and reuse them across databases. Pairing that discipline with continuous validation through USDM Cloud Assurance for atrify is how you stay compliant as both the regulations and the vendor cloud keep changing.
Watch the On-Demand Webinar
Fill out the form on this page to watch Global UDI Data Management – The New Paradigm on demand. Prefer to talk through your specific UDI and EUDAMED challenges with our team? Contact us and we'll help you build a strategy for managing your device data across global databases.
About the Presenters
Jay Crowley, Vice President of Medical Device Solutions and Services, USDM Life Sciences
Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system. At USDM, Jay provides business process, technology, and compliance solutions for the regulated life sciences industry, and consults with medical device manufacturers to help them achieve regulatory compliance and a competitive advantage with UDI implementation.
Lionel Tussau, Director, Strategic Industries, atrify
Lionel is leading the global healthcare strategy at the product content solution provider atrify, a company enabling UDI registrations into regulatory databases (such as EUDAMED) and GDSN connections between manufacturers, wholesalers, GPOs, and hospitals. He represents atrify in MedTech Europe (chairman of the EUDAMED IT Expert group), is an observer in the EUDAMED MDCG working group, and is a member of the GS1 Global Healthcare Leadership Team.
Jim Macdonell, Vice President of Eastern Region, USDM Life Sciences
Jim is responsible for driving solutions for our medical device customers and staying at the forefront of regulatory and technology challenges facing the medical device industry. Jim is a seasoned consulting leader with more than 25 years of experience. He developed many of the regulatory compliance and IT programs at USDM including; our Unique Device Identification (UDI) program and EU MDR / IVDR programs.
FAQ: Global UDI Data Management
What is a national UDI database?
A national UDI database is the system a regulator uses to collect and store Unique Device Identification data for medical devices. Multiple regulators have or are launching them — including the US, EU, SFDA, NMPA, KFDA, and HSA — with other regulators following close behind.
Why is managing UDI data across multiple databases so challenging?
The challenge for device manufacturers is creating and submitting the required data to each national database and maintaining that data — and regulatory compliance — over time. Using and reusing data attributes across databases requires a thorough understanding of the required data, accurate mappings, and transformations of the data attributes.
What other systems and use cases rely on UDI data?
Beyond regulatory submission, other users and use cases for UDI (or UDI-like) data are emerging — including commercial, payment, supply chain, and postmarket surveillance such as registries. Providing accurate and timely data to these systems is also critical.
What is USDM Cloud Assurance for atrify?
USDM and atrify have supplemented USDM's UDI services and technology with USDM Cloud Assurance for atrify. It addresses the initial validation and the ongoing release-management maintenance of that validation, so you can assure continuous compliance through the atrify cloud updates.
How do I watch the webinar?
Fill out the form on this page to watch the on-demand webinar, or contact us to discuss your global UDI data management and submission needs directly.