22-April-2024

First International Conference on Medical Device Risk Management

Minneapolis, MN, USA

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About the Event

The First International Conference on Medical Device Risk Management will be held on 22-April-2024 in Minneapolis, MN, USA.

The top world-experts in medical device safety risk management will be attending this exciting conference to speak and share their insights with the community. Medtronic CEO, Geoff Martha, will kick off this conference to highlight the importance of patient safety to the MedTech Industry. Dr. Olaf Hedrich, the corporate VP of Medical Safety at Medtronic, will deliver a keynote address. Ms. Erin Keith, the FDA senior advisor on compliance and quality, will speak on the FDA’s future expectations from the industry.

There will be ample opportunities to network and make meaningful connections with your peers across the industry.

AGENDA OF Event

Time	Speaker	Topic
8:00	Bijan Elahi	Welcome, message from the Chair
8:10	Geoff Martha Medtronic CEO	Keynote- The central importance of patient safety
8:25	Dr. Olaf Hedrich Medtronic Corporate VP, Medical Safety	Keynote – A physician’s perspective on device safety
8:50	Professor Kambiz Pourrezaei School of Biomedical Engineering at Drexel University	The need for academic education on risk management in biomedical Engineering
9:00	Erin Keith FDA Senior Advisor Compliance & Quality, OPEQ/CDRH	Quality Management System Regulation: Emphasis on Risk Management and Risk Based Decisions
9:30	Tina Krenc Principal Consultant KTA Compliance, ISO 14971 author, Chair ISO/TIR 24971, AAMI Educator	Determining Criteria for Risk Acceptability
10:00	Keith Morel, PHD VP of Regulatory Compliance Qserve Group	Justifying criteria for risk acceptability – challenges with synthesizing various sources of data
10:30	Networking break
11:00	Binesh Kumar, PHD Medtronic Technical Fellow	Comparative Study of Generative Models for Early Detection of Failures in Medical Devices
11:30	Jerry Xiao Expert: Risk Management, AI/ML, Robotic Surgery	Creating a GPT-Powered AI System for Risk Assessment
12:00	Lunch break
13:00	Mercedes Massana Consultant, CSQE, CRE Expert: Risk Management, Safety Assurance Cases	Utilizing System Architecture to drive Risk Management Activities
13:30	Michael Asmalsky Risk Management and Usability Engineering Manager, Philips, Germany. ISO 14971 author	State of the Art – What is it – How to Use it ?
14:00	Fubin Wu Co-founder & President GessNet. Expert: Risk Management, Cybersecurity, Safety Assurance Cases	What a Decade of Infusion Pump Safety Assurance Cases has Taught Us About RM Improvement
14:30	Byron Murray Senior Principal Quality Engineer, Medtronic	Factors to Consider When Choosing a Software Tool for Risk Management
15:00	Networking break
15:30	Taylor Dieringer CQE, CRE, Expert – Postmarket Risk Management Strategist	Practical Strategies for Integrating Post-Market Trending with Risk Management
16:00	Edwin Bills Principal Consultant, ISO 14971 author, AAMI Educator	Intersections of ISO 13485:2016 and ISO 14971:2019
16:30	Steve Gompertz Partner, QRx Partners Expert in Quality Systems	Risk-Based Approach vs. Risk Management
17:00	Social Hour