Ginny Hu
Company: Dexcom
Job title: Director, Regulatory Affairs
Seminars:
Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together 3:00 pm
Defining SaMD, SiMD, Digital Therapeutics, CDS Exploring the different regulatory expectations for each branch to understanding the correct path to market and how to add a new indication depending on your device type Providing background for regulatory expectations – during development, in submission, post market Linking to other important SW regulations as considerations (production, communication…Read more
day: Pre-Conference Track 2 PM
Roundtable Discussion: Building out a Software Bill of Materials for Embedded Packages, Open Source & Third-Party Software to Meet FDA Requirements & Ensure Regulatory Approval 2:30 pm
Addressing the vague regulatory expectations regarding the quantity of tangible elements required in the software Bill of Materials, and exploring strategies to meet these expectations without compromising efficiency Clarifying FDA expectations on showcasing direct and/or transitive dependencies within software composition analysis, with a focus on identifying the optimal levels of dependencies needed to satisfy regulatory…Read more
day: Day One