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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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 understating of the required data, accurate mappings, and transformations of the data attributes.
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.
The on-demand webinar discusses the following:
- 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
Check out a sneak peek below:
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.