May 24, 2022 at 10am EST
Starting with the US FDA, medical device regulators are instituting Unique Device Identification (UDI) compliance requirements in regional markets around the world. Staying compliant can be viewed as both a challenge and an opportunity to institute a more robust regulatory management process. Leading manufacturers are leveraging the digital thread gateway to submit UDI data in a more sustainable fashion, which streamlines validation and centralizes UDI product data for a shared, global view into submissions to health authorities.
PTC, Kalypso, and Reed Tech will walk through the following:
- Lessons learned from our Healthcare Executive Advisory Council and EU MDR working group
- Leading practices for harmonizing R&D and UDI data
- Developing a scalable strategy for current and emerging UDI regulations
- Synergistic effect when connecting the digital thread to SingleSource™
- Business impact achieved across product development, regulatory, and supply chain
Speakers
David Wolf, Certified Biomedical Auditor and Quality Engineer, PTC
John Hubert, Digital Regulatory Management Practice Lead, Kalypso
Haley Lentz, Director of Sales, Reed Tech Life Sciences