Monika McDole-Russell
Company: Medtronic
Job title: Sr. Director, Regulatory Affairs
Seminars:
Exploring the Potential of Predetermined Change Control Plans (PCCP) in Medical Device Authorization 2:00 pm
Exploring the legislation that enables companies to obtain FDA authorization for changes without requiring separate approvals Seeking insights into the experiences of companies attempting to secure PCCP authorization and the potential benefits in terms of expedited modifications Considering the guidance provided for AI/ML devices and exploring the broader applicability of PCCP across various types of…Read more
day: Day Two