Speakers
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