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:
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