Web Conference (hosted by Australia)

Meeting no
22
Date
-
Location
Australia

Jurisdictional updates

Working group updates

Regulated Product Submissions
Good Regulatory Review Practice
Adverse Event Terminology
Personalized Medical Devices
Medical Device Cybersecurity Guide
Artificial Intelligence Medical Devices
Software as a Medical Device

Joint IMDRF/DITTA Workshop - Standards for Health Software

Safety and Performance - Developing “THE” Comprehensive Standard : Needs and Challenges - Industry Perspective
Pat Baird (Philips, GMTA)
Security - Enlisting All Security Forces: Needs and Challenges - Industry Perspective
Varun Verma (Philips, DITTA Cybersecurity WG vice-chair)
Artificial Intelligence / Machine Learning - Can “one size” fit all?: Needs and Challenges - Industry Perspective
Martin Meyer (Siemens Healthineers, DITTA)
Artificial Intelligence / Machine Learning - Can “one size” fit all?: Perspective from ISO/TC 210
Peter Linders, Chair ISO/TC 210
Response from the SDOs and IMDRF: Perspective from IMDRF Standards Liaison Program
Scott Colburn (US FDA)

Joint IMDRF/GMTA Workshop – Medical Devices and Artificial Intelligence

Current and Emerging AI and Medical Device Technologies and Products: AI technologies and their application in health care settings
Kyu-Hwan Jung, Ph.D, VUNO
Current Regulatory Approaches to AI and Medical Devices: IMDRF’s AI and medical devices work
Mr Lin Anle, Singapore
Opportunities for AI and Medical Device Regulation: Opportunities for global convergence and prioritization of AI
Subok Park, LUNIT Inc.
Considerations for Mitigating Bias in AI and Medical Devices: Unintentional sources of bias that can affect the performance of AI and medical devices
Yarmela Pavlovic, Medtronic
Considerations for Mitigating Bias in AI and Medical Devices: Unintentional sources of bias that can affect the performance of AI and medical devices
Dongmin Kim, JLK Inc