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UDI Beyond Borders

Harnessing Your Data for Medical Device Identification

The 12th annual UDI Conference is the industry gathering for medical device manufacturers, distributors, GPO’s and hospital systems to work through new and anticipated global UDI-related policies; dive into areas of confusion; create strategic roadmaps for cohesive implementation; grasp the impact on the healthcare ecosystem; and understand what is developing on the international UDI landscape.

We are excited to bring back this UDI event, hosted virtually by USDM Life Sciences. Thoughts leaders from the FDA, device companies, solution providers, and consultancies will lead the discussions. See the agenda below for this complimentary event.

NOVEMBER 9, 2022
10:00 AM – 1:00 PM EST  |  7:00 AM – 10:00 AM PST  |  4:00 PM – 7:00 PM GMT

UDI Conference 2022

AGENDA

The Global UDI Landscape

The final US UDI deadline will have passed (24 September 2022). The initial EU MDR/IVDR UDI label and package requirement deadline has also passed (MDR-complaint implantable and class III devices were 26 May 2021).  More MDR and IVDR deadlines are fast approaching (e.g., MDR complaint Class IIa/b devices is 26 May 2023).  At the same time, other regulators have (e.g., China, Singapore, Saudi Arabia, Columbia) or are working on (e.g., Canada, Australia, Egypt, Brazil) their UDI requirements. This session will cover global UDI requirements, their similarities and differences, and their impact on device manufacturers.

Panelists:

  • Jay Crowley, VP Medical Device Solutions, USDM Life Sciences
  • Dennis Black, UDI Program Director, BD
  • Geraldine Lissalde Bonnet, VP Healthcare, GS1 Global
  • Indira Konduri, FDA CDRH

 

EU MDR & EU IVDR Challenges

The new EU medical device regulations (MDR and IVDR) introduce many new challenges for device manufacturers. This session will address the many challenges and issues with MDR/IVDR UDI application, Basic UDI-DI (and Master UDI-DI), EUDAMED, the role of other economic operators (authorized reps, importers, distributors), the unique UDI application requirements for systems, procedure packs and IVD kits, and the various mandatory QMS implications.

Panelists:

  • Jay Crowley, VP Medical Device Solutions, USDM Life Sciences
  • Lionel Tussau, Healthcare Global Lead, atrify
  • Wendy Jackson, Fellow QA Engineer, Global UDI Program, Boston Scientific Corp
  • Tania Pearson, Sr Regulatory Affairs Manager, Medtronic

 

Data Quality & Data Management Considerations

As regulators, purchasers, and other global stakeholders begin to develop and implement country or regulator-specific UDI or UDI-like systems – they are not only trying to address device identification – but also support particular national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement). These new regulatory, commercial, and patient-safety use-cases create novel and complex challenges for device manufacturers, who now must establish and maintain robust global systems and processes that allow them to develop, maintain and submit the ever-growing (and changing) information to these various systems and stakeholders. This session will discuss the melding of these information needs and ways in which device manufacturers, healthcare providers, researchers, patients, purchasers, insurers, and regulators can work together to achieve the shared goals of improving device safety, effectiveness, healthcare quality, and patient safety, and reducing risks and healthcare costs.

Panelists:

  • Jay Crowley, VP Medical Device Solutions, USDM Life Sciences
  • Terrie Reed, Chief Strategy Officer, Symmetric Health Solutions
  • Gary Saner, Sr Mgr, Information Solutions, Reed Tech
  • Ardi Batmanghelidj, President & CEO, Innovatum Inc.

 

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UDI Conference 2022 (Virtual and Free)

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