Speakers
Jason Gorman
Director, Global Product Regulatory Affairs
ResMed
Day One Track B PM
Wednesday 25th June 2025
4:30 pm | Harmonizing Quality Management with Regulatory Expectations: Bridging the Gap
Ephrat Most
Director, Software Quality Program
Medtronic
Pre-Conf Track A Mid-day
Tuesday 24th June 2025
12:00 pm | Harnessing AI in Medical Device Software Development: Innovation, Efficiency & Ethical Boundaries
Michael Iglesias
Associate Director, Quality Assurance
Merck
Pre-Conf Track B Afternoon
Tuesday 24th June 2025
3:00 pm | Practical Insights into Regulatory Submissions & Documentation Best Practices for SaMD, SiMD, Digital Therapeutics & CDS
Joshua Guo
Associate Director - Emerging Technologies Regulatory Affairs & Quality Assurance Lead
Biogen
Pre-Conf Track B Afternoon
Tuesday 24th June 2025
3:00 pm | Practical Insights into Regulatory Submissions & Documentation Best Practices for SaMD, SiMD, Digital Therapeutics & CDS
Manil Asija
Principal Engineer Quality Engineering
Analog Devices
Conference Day One Morning
Wednesday 25th June 2025
9:00 am | Securing Cloud-Connect Medical Devices: Interoperability & Data Privacy
James Asimah
Director & Head of Cyber Security & Government, Risk & Compliance
Highridge Medical
Conference Day One Morning
Wednesday 25th June 2025
10:00 am | Threats, Attacks, & Vulnerabilities
Andrew O’Keeffe
Executive Director, Global Digital Quality
Olympus
Pre-Conf Track A Afternoon
Tuesday 24th June 2025
Stephen Odaibo
Founder, Chief Executive Officer & Software Architect
RETINA-AI Health, Inc
Pre-Conf Track A Afternoon
Tuesday 24th June 2025
3:00 pm | Building Resilient AI-Cybersecurity Frameworks: Practical Strategies for Development teams Amid Regulatory Gaps
Adam Heroux
Vice President, Quality Assurance & Regulatory Affairs
Kheiron Medical
Pre-Conf Track B Mid-day
Tuesday 24th June 2025
12:00 pm | Building Practical AI Validation Frameworks in the Changing Regulatory Landscape
Eleonora Chakraborty
Associate Director, Regulatory Affairs, Strategic Global Labeling, Combination Products & Devices
Abbvie
Conference Day Two
Thursday 26th June 2025
9:00 am | Panel Discussion: Aligning Engineers & Regulators for Seamless Collaboration
Pre-Conf Track B Morning
Tuesday 24th June 2025
9:00 am | Harmonizing Global Regulatory Strategies to Simplify Medical Device Submissions & Expand Market Reach
Sam Rajkumar
Director, Regulatory Affairs,Quality Assurance & Security Digital Healthcare
Analog
Pre-Conf Track B Morning
Tuesday 24th June 2025
9:00 am | Harmonizing Global Regulatory Strategies to Simplify Medical Device Submissions & Expand Market Reach
Don Bigler
VP of Engineering
IMVARIA
Day One Track A AM
Wednesday 25th June 2025
12:00 pm | Efficient Iterations: Reducing Time-to-Market for Medical Devices
Joshua Kupke
Director, Research & Product Development
Enovis
Day One Track B Post-Lunch
Wednesday 25th June 2025
2:30 pm | Navigating Product Change Control: Balancing Innovation & Regulatory Compliance
Richard Jackson
Director of Software
FluxErgy
Day One Track B PM
Wednesday 25th June 2025
4:00 pm | Accelerating Approvals: Leveraging the FDA’s Product Change Control Plans (PCCPs)
Adam Heroux
Vice President of Quality & Regulatory Affairs
Kheiron Medical
Dinendra Ramachandran
Vice President Digital Health Solutions
Convatec
Day One Track A PM
Wednesday 25th June 2025
4:30 pm | Building AI Capabilities within a Medical Device
Andrew Wichmann
Senior IP & Licensing Manager, Digital Technology
John Hopkins
Day One Track A Post-Lunch
Wednesday 25th June 2025
2:00 pm | Leveraging Open-Source Tools for Medical Device Software Development
Neeraj Mainkar
Vice President of Software Engineering & Advanced Technology
Proprio
Day One Track A Post-Lunch
Wednesday 25th June 2025
2:30 pm | Building Efficient Data Pipelines: Accelerating AI Model Training & Validation in Regulated Environments
Seth Kuzdzal
Senior Vice President, Quality Assurance & Regulatory Affairs
Biofourmis
Day One Track B AM
Tuesday 24th June 2025
12:00 pm | Demystifying AI Transparency: Building Systems That Regulators Trust
Tura Oulette
Director Regulatory Affairs
Straumann
Day One Track B AM
Tuesday 24th June 2025
12:30 pm | Optimizing SBOMs & Change Control Management for Regulatory Compliance in Medical Device Software
Attrayee Chakraborty
Quality System Engineer
Analog Devices
Conference Day Two
Thursday 26th June 2025
9:00 am | Panel Discussion: Aligning Engineers & Regulators for Seamless Collaboration
Brian Schick
Digital Product Strategy & Development Lead
Takeda
Conference Day Two
Thursday 26th June 2025
9:45 am | Collaborative Risk Assessment for Faster Approvals
Srutiparna Lahkar
Senior Quality Lead
Genentech
Conference Day Two
Thursday 26th June 2025
10:15 am | Key Considerations for Sponsors & Manufacturers of SaMDs & Medical Devices in Clinical Trials
Joshua Park
Chief Executive Officer
Global Biomedical
Conference Day Two
Thursday 26th June 2025
11:30 am | Roundtable: The Role of Edge Computing in Real-Time Healthcare: Opportunities & Challenges
Timothy Ruchti
Director, Algorithms
Nihon Kohden Corporation
Conference Day Two
Thursday 26th June 2025
12:00 pm | Transforming Patient Care with Predictive Algorithms & Real-Time Physiological Data
Jason Domask
Director, Software Engineering
HeartSciences
Conference Day Two
Thursday 26th June 2025
1:30 pm | HeartSciences Pillars of Excellence: A Story About how we Built a Medical Device Data System (MDDS) & Class II Cardiovascular Machine Learning- Based Notification Software in Record Time
Phani Bidarahalli
Senior Director, Surgical Innovations, Research & Development
Medtronic
Conference Day Two
Thursday 26th June 2025
2:00 pm | Data-Driven Innovation: Leveraging Big Data & AI in Development & Validation
Sucheth Koppa
Head of Software Computational Science Informatics Verification Validation, Research & Development
Roche
Conference Day Two
Thursday 26th June 2025
2:30 pm | Roundtable: Shaping the Future of Medical Devices: Innovation, Compliance, and Patient-Centric Development
Andrew O’Keeffe
Executive Director, Global Digital Quality
Olympus
Seth Kuzdzal
Senior Vice President, Quality Assurance & Regulatory Affairs
Biofourmis
Sarah Rickert
Director of Quality & Regulatory Affairs
Werfen
Sam Rajkumar
Director, Regulatory Affairs, Quality Assurance & Security Digital Healthcare
Analog Devices
Richard Jackson
Director of Software
FluxErgy
Phani Bidarahalli
Senior Director, Surgical Innovations, Research & Development
Medtronic
Neeraj Mainkar
Vice President, Software Engineering
Vicarious Surgical
Michael Iglesias
Associate Director, Quality Assurance
Merck
Manil Asija
Principal Engineer Quality Engineering
Analog Devices
Joshua Park
Chief Executive Officer
Global Biomedical
Joshua Kupke
Director, Research & Product Development
Enovis
Joshua Guo
Associate Director, Emerging Technologies Regulatory & Quality Lead
Biogen
Jason Gorman
Director, Global Product Regulatory Affairs
ResMed
Jason Domask
Director, Software Engineering
Heart Sciences
James Asimah
Director and Head of Cyber Security & Government, Risk & Compliance
Highridge Medical
Ephrat Most
Director, Software Quality Program
Medtronic
Eleanora Chakraborty
Associate Director, Regulatory Affairs, Strategic Global Labeling, Combination Products & Devices
Abbvie
Don Bigler
Vice President, Engineering
IMVARIA
Dinendra Ramachandran
Vice President Digital Health Solutions
Convatec
Brian Schick
Director, Digital Product Strategy & Development Lead
Takeda
Attrayee Chakraborty
Quality Systems Engineer
Analog Devices
Andrew Wichmann
Senior IP & Licensing Manager, Digital Technology
John Hopkins
Stephen Odaibo
Founder, Chief Executive Officer & Software Architect
RETINA-AI Health
Srutiparna Lahkar
Senior Quality Lead
Genentech
Sucheth Koppa
Head of Software Computational Science Informatics Verification Validation, Research & Development
Roche
Tara Larson
Product Security Director, Chief Security Architect
Abbott Laboratories
Timothy Ruchti
Director, Algorithms
Nihon Kohden Corporation
Tura Oullette
Director of Regulatory Affairs
Straumann Group