Speakers

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Ashley Miller
Director of Regulatory Affairs
Digital Diagnostics

Day One

Wednesday, May 18 2022

8:30 am | Opening Panel: Overcoming the Challenges of a Fast-Paced Software World and a Slow-Paced Regulatory World

Wendy Ji
Principal Verification Software Engineer
Medtronic

Day One

Wednesday, May 18 2022

4:05 pm | Test Planning for a Medical Device

8:30 am | Opening Panel: Overcoming the Challenges of a Fast-Paced Software World and a Slow-Paced Regulatory World

Arnab Ray
Director of Product Cybersecurity
Abbott

Derek Mackenzie
Product Manager
Click Therapeutics

Day One

Wednesday, May 18 2022

4:35 pm | Panel Discussion: Understanding Key Challenges & Solutions of Agile Methodology

Ephrat Most
Senior Software Design Quality Engineering Manager
Medtronic

Day Two

Thursday, May 19 2022

2:15 pm | Interactive Roundtable Discussion Groups

12:15 pm | Implementing Risk Analysis into the Software Development Lifecycle

Sharief Taraman
Chief Medical Officer
Cognoa

Day One

Wednesday, May 18 2022

1:45 pm | Panel Discussion: Discussing the Different Applications for AI-ML in Healthcare

Day Two

Thursday, May 19 2022

9:45 am | Practical Application of AI/ML to Improve Outcomes & Streamline the Diagnostic/Care Journey of Paediatric Behavioural Health Conditions

Jeff Hersh
Chief Medical Officer
GE Healthcare

Day Two

Thursday, May 19 2022

9:00 am | Machine Learning Considerations for Device Developers

Jeff McBride
Chairman and Founder of the Panacea Community and SW Quality Specialist European Device Solutions
AAMI

Day One

Wednesday, May 18 2022

11:45 am | Understanding How to Classify Software within Global Frameworks

Jim Jacobson
Principal Cybersecurity Officer
Siemens Healthineers

Day Two

Thursday, May 19 2022

11:45 am | Security Concerns for Health Delivery Organizations

Kelly Weyrauch
Committee Member & Lead Author of AAMI TIR45
AAMI

Day One

Wednesday, May 18 2022

4:35 pm | Panel Discussion: Understanding Key Challenges & Solutions of Agile Methodology

3:15 pm | Using Agile Development for Medical Devices Systems - Guidance from AAMI TIR45

Randy Horton
Co-Chair, Software Mgmt Working Group 10 and TIR 115
AAMI

Day Two

Thursday, May 19 2022

2:15 pm | Interactive Roundtable Discussion Groups

Scott Thiel
Head of Regulatory Policy & Intelligence
Hologic

Day One

Wednesday, May 18 2022

2:30 pm | Panel Discussion: Filling the Gaps of Knowledge for New Software Developers in the Industry

Stephen Odaibo
CEO & Founder
RETINA-AI Health

Day One

Wednesday, May 18 2022

1:45 pm | Panel Discussion: Discussing the Different Applications for AI-ML in Healthcare

2:30 pm | Panel Discussion: Filling the Gaps of Knowledge for New Software Developers in the Industry

12:15 pm | End-to-End Case Study on Getting FDA Approval for AI SaMD

Day Two

Thursday, May 19 2022

10:15 am | AI SaMD Start Up Case Study: Setting Up a Quality Management System

3:15 pm | Chair’s Closing Remarks & End of Conference

8:50 am | Chair’s Opening Remarks

Shawnnah Monterrey
Chief Executive Officer
Beanstock Ventures

Day Two

Thursday, May 19 2022

11:15 am | Examining Benefits & Challenges with Developing a Software Platform

Warren Dennis
Principal Software Engineer
Mayo Clinic

Day One

Wednesday, May 18 2022

4:35 pm | Panel Discussion: Understanding Key Challenges & Solutions of Agile Methodology

Liz Asai
Vice President of Strategic Development
Digital Diagnostics

Day One

Wednesday, May 18 2022

1:45 pm | Panel Discussion: Discussing the Different Applications for AI-ML in Healthcare

Karl Fleisher
Senior Agile Transformer
GE Healthcare

Day One

Wednesday, May 18 2022

4:35 pm | Panel Discussion: Understanding Key Challenges & Solutions of Agile Methodology

John Beebe
Software Quality Manager - Surgical Robotics
Medtronic

Day Two

Thursday, May 19 2022

1:45 pm | Three Lessons from the Verification of Complex Software Systems

Brendan O’Leary
Acting Director, CDRH Digital Health Center of Excellence
U.S. Food and Drug Administration

Day One

Wednesday, May 18 2022

David Leichner
CMO
Cybellum

Day One

Wednesday, May 18 2022

9:15 am | Cybersecurity Vulnerability Management, SBOMs and Compliance

Rosalind Beasley
VP Digital Innovation
Dot Compliance Inc

Day One

Wednesday, May 18 2022

8:30 am | Opening Panel: Overcoming the Challenges of a Fast-Paced Software World and a Slow-Paced Regulatory World

Mike Fidler
Regional Sales Engineer
Zimperium

Day Two

Thursday, May 19 2022

9:30 am | Securing Your Device Connected Apps in the Current mHealth Threat Landscape

Asavari Dandekar
Partner
IZiel Healthcare

Day One

Wednesday, May 18 2022

11:15 am | Outlining Optimal Methodology of Managing Compliance for SOUPs, CSV & Tools

Durga Kulkarni
Partner
IZiel Healthcare

Day One

Wednesday, May 18 2022

11:15 am | Outlining Optimal Methodology of Managing Compliance for SOUPs, CSV & Tools

Pat Baird
Senior Regulatory Specialist – Head of Global Software Standards
Philips

Day One

Wednesday, May 18 2022

5:20 pm | Chair’s Closing Remarks

8:20 am | Chair’s Opening Remarks