PW 2014 Presentation: GE Healthcare's Unique Device Identification (UDI) Regulatory Publication BPM Logic for Medical Devices
LUCAS DE FABRY, PROGRAM MANAGER FOR PRODUCT IDENTITY & UDI PUBLICATION, GE HEALTHCARE
NATHANIEL BAUER, PROJECT LEADER FOR UDID PUBLICATION MANAGEMENT, GE HEATHCARE
Across the globe, regulatory authorities have started releasing firm guidelines for the traceability and labeling of medical devices. In response, companies are required to hone and strengthen their processes for product labeling and identification. In addition, medical device manufacturers must implement Unique Device Identification (UDI) into their production procedures and subsequently publish specific data attributes relevant to a given medical device for review and record in the regulator’s database. In order to keep pace with the changing regulatory landscape, the functional Regulatory Team requires a tool that is both robust and reliable to consistently capture, manage and organize the orderly publication of GEHC medical device data.
In this session you will learn:
- How to build a data structure supporting the Medical Device Publication Requirements calculation engine and global expansion
- About the logical steps to follow to submit a Medical Device Publication, events and reporting needs
- About the business benefits (manual vs systemic publication)