About the recorded Online Session
The International Medical Device Regulators Forum (IMDRF) set out basic UDI requirements in their guidance document Unique Device Identification (UDI) of Medical Devices. As regulators, purchasers, and other global stakeholders begin to develop and implement UDI (or UDI-like) systems, they are also trying to address device identification initiatives and support both national or local concerns.
New global UDI use cases are creating challenges for device manufacturers who must establish and maintain robust systems and processes that allow them to submit to various national systems and other stakeholders the ever-growing (and ever-changing) product information requirements.
This online session includes:
- Changes in various regulatory, commercial, and patient-safety information requirements
- Ways in which device manufacturers can address these growing needs
- How to think locally, nationally, and globally to minimize compliance burdens
Jay Crowley, Vice President of Unique Device Identification Solutions, USDM Life Sciences
Stefan Domdey, Director Global Sales, atrify GmbH