Understanding ISO/DIS 10993-3 Updates: A Focus on Developmental and Reproductive Evaluations (DART) for Medical Devices

Event Date(s) :
Wednesday, Nov 12, 2025
Tags :
Webinar
ISO/DIS 10993-3
Developmental and Reproductive Evaluations
DART
Megan A. Hahn, PhD, DABT
Kimberly Ehman, PhD, DABT

Abstract

This webinar will address proposed changes to ISO 10993-3, specifically evaluations of developmental and reproductive (DART) toxicity for medical devices.

During this webinar, you will learn:

  • What changes are proposed in ISO/DIS 10993-3
  • How to interpret data from various developmental and reproductive (DART) study designs
  • When DART endpoints should be considered for your device
  • Approaches for evaluating DART endpoints in the toxicological risk assessment (TRA)

Register now