MedCon 2025 has been announced!

April 23 – 25, 2025

Columbus, OH

AFDO RAPS Healthcare Products Collaborative
MedCon Conference

MedCon took place April 24-26, 2024

Columbus, OH

Workshop from MedCon 2024


AI/ML Enabled Medical Devices from a Quality & Regulatory Perspective: an Interactive Workshop

As the number of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices cleared by FDA approaches 1,000, the challenges associated with incorporating this technology are still significant. The level of understanding around AI/ML fundamental concepts in the industry is still very low; regulatory frameworks are not yet designed to take advantage of the greatest benefits of AI/ML, and there are many barriers to trust in these technologies to safely and effectively diagnose and treat patients (e.g., bias, transparency, explainability).

This daylong workshop aligns attendees on vocabulary and concepts and includes a hands-on session that takes a simple AI algorithm and moves it through the training, testing, and tuning process. The workshop will also include:

An overview of current and future regulatory trends in AI/ML-enabled medical devices

The impact of AI/ML on Quality and Regulatory functions

Technology, intended use, and trustworthiness challenges that the medical device industry and regulators must address

A case study walking attendees through development, submission, clearance, and deployment of an AI/ML-enabled medical device

Don’t miss this opportunity to engage with thought leaders who have had significant impact on the global discussion around these topics.

workshop Facilitators

Cassie Scherer


Erez Kaminski


Eric Henry

King & Spalding

Jason Brooke

Brooke & Associates

Mandar karhade


Yarmela Pavlovic


APRIL 23, 2024 — MedCon Workshop Agenda

Location: Tower 401 Lobby Level Elijah Pierce AB

9:00 a.m. – 10:00 a.m.


  • Welcome and Introduction to the Workshop
  • Brief Overview of AI in the Medical Devices Industry (technologies and use cases)
  • Key AI Concepts (machine learning, natural language processing, computer vision)

Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Erez Kaminski, CEO & Founder, Ketryx

10:00 a.m. – 10:45 a.m.

Regulatory Landscape for AI in Medical Devices

  • Overview of current and future regulatory frameworks (U.S. and global) for medical devices

Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

10:45 a.m. – 11:00 a.m.


11:00 a.m. – 12:00 noon

Quality Assurance with AI in Medical Devices

  • Medical device AI/ML use cases 
  • Role of AI supporting the QMS 
  • Role of AI in enhancing quality control processes (manufacturing) 
  • Addressing challenges and opportunities in compliance 
  • AI and safety risk management 

Jason Brooke, Attorney & Managing Member, Brooke & Associates 

12:00 noon – 1:00 p.m.


1:00 p.m. – 2:00 p.m.

Future Trends and Challenges

  • Emerging trends in AI for medical devices and their regulatory impact 
  • Bias 
  • Transparency/explainability 
  • Nutrition labels 
  • Assurance labs 
  • Other anticipated regulatory challenges and potential solutions for AI/ML 

Yarmela Pavlovic, VP Global Regulatory Affairs, Strategy & Policy, Medtronic 

Cassie Scherer, Senior Director U.S. Regulatory and Global Digital Health Policy, Medtronic

2:00 p.m. – 3:00 p.m.

Interactive Session: Building an AI-Enabled Medical Device Overview

  • Overview of a sample medical device project 
  • Hands-on demo using AI tools 

Mandar Karhade, Founder, Citingale

3:00 p.m. – 3:15 p.m.


3:15 p.m. – 4:00 p.m.

Case Studies: Successful Implementation of AI in Medical Devices

  • Real-world examples of AI integration in medical devices 
  • Highlighting positive outcomes in terms of efficiency and compliance 
  • Lessons learned and best practices from these cases 

Erez Kaminski, CEO & Founder, Ketryx 

4:00 p.m. – 4:30 p.m.

Conclusion and Networking

  • Recap of key takeaways 
  • Opportunities for further learning and collaboration 

Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding 

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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