Monika McDole-Russell

Company: Medtronic

Job title: Sr. Director, Regulatory Affairs

Seminars:

Leveraging Regulatory Affairs from the Initial Stages of Device Development to Ensure Regulatory Compliance & Speed to Market 11:45 am

Implementing comprehensive procedures early in device development to align with regulatory requirements and streamline approval processes Best practices for incorporating Regulatory Affairs partners from project kick-off to mitigate risk and optimize time to market Addressing potential regulatory hurdles proactively during initial stages to facilitate smoother device development and regulatory approvalRead more

day: Day One

Panel: Embedding the Cybersecurity Value System Upstream to Ensure Security Processes Are Implemented in the Early Architecture to Minimize Downstream Security Compliance Issues. 2:00 pm

Increasing the understanding behind cybersecurity literacy which does not require cybersecurity expertise Through this managerial committee ensuring smoother collaboration across wider members of the team Solutions to overcome challenges in implementing this internal shift in medical device companiesRead more

day: Day Two