Schedule

With three days, three tracks, and 30+ experts speaking, there's sure to be something for everyone. Which sessions will you attend? Sessions are still being added, current session times are subject to change.

2020/06/02

4 Quality System Musts for Medtech Startups to Get Safer Products to Market Faster

June 02, 2020, 02:00 PM
Jon Speer Founder & VP of QA/RA, Greenlight Guru
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An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Standard’s Working Group

June 02, 2020, 02:55 PM
Ed Bills, ASQ Fellow, RAC & Tom Rish Greenlight Guru
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When to “Flip the Switch”- Balancing Late Feasibility and Early Design Controls

June 02, 2020, 03:50 PM
Jamison Float, Chad Gibson & Wade Schroeder Priority Designs, CMD MedTech & Greenlight Guru
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Design Considerations to Maximize Medical Device Cloud Connectivity

June 02, 2020, 04:45 PM
Keith Drake Ph.D. & Chris DuPont Galen Data, Inc. & Galen Data
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Game Changing Product Definition Tactics

June 02, 2020, 06:00 PM
Scott Phillips CEO, StarFish Medical, ViVitro Labs Inc.
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Medical Device Project Pitfalls and How to Avoid Them

June 02, 2020, 06:55 PM
Peter Sebelius Medical Device HQ, Founder
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Why Design Validation is More Than Testing: How do we validate our validation?

June 02, 2020, 07:50 PM
Michael Drues President, Vascular Sciences
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How User Experience Design and Human Factors Engineering can Accelerate Product Development

June 02, 2020, 08:45 PM
Miles Buroker & Milton Yarberry UserWise & ICS
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Best Practices for Preparing and Conducting Pre-Submission Meetings

June 02, 2020, 09:40 PM
Isabella Schmitt, RAC Regulatory Affairs Consultant, Proxima Clinical Research
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2020/06/03

How to Implement and Maintain an Audit-Ready QMS Leveraging Technology

June 03, 2020, 02:00 PM
Jon Speer Founder & VP of QA/RA, Greenlight Guru
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Economic Operators under EU MDR

June 03, 2020, 02:55 PM
Monir El Azzouzi CEO, Easy Medical Device
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Prioritizing Documentation for MDR Transition Planning

June 03, 2020, 03:50 PM
Evangeline Loh VP of Regulatory Affairs, Emergo by UL
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Recent FDA feedback Regarding Extractable and Leachable (E&L) Testing and How to make sure FDA will accept your testing protocol

June 03, 2020, 04:45 PM
Taylor Brown, Matthew Jorgensen & Thor Rollins Greenlight Guru, Nelson Labs & Nelson Labs
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IVDR Readiness Checklist

June 03, 2020, 06:00 PM
Oliver Eikenberg & Jesseca Lyons Emergo by UL & Greenlight Guru
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Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

June 03, 2020, 06:55 PM
Carolyn Guthrie Director of QA / RA, Kapstone Medical
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Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Marked, is that Device Safe and Effective?

June 03, 2020, 07:50 PM
Michael Drues President, Vascular Sciences
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Strategies for ensuring a Medical Device released under EUA will stay on the market after EUA expires

June 03, 2020, 08:45 PM
Brad Graves & Cathy Wilburn RND Group & RND Group
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Navigating the 1 year EU MDR Extension

June 03, 2020, 09:40 PM
Chris Mauch Manager | Life Science Advisory, KPMG
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2020/06/04

The post-COVID Value Shift & How MedTech Companies can Capitalize

June 04, 2020, 02:00 PM
Richard Charter Vice President MedTech Market Access - Europe & Asia Pacific, Alira Health
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How to get your COVID-19 Related Medical Device to Market Under FDA Emergency Use Authorization (EUA)

June 04, 2020, 02:55 PM
Kyle Rose Rook Quality Systems, President
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Why Remote Research Is (or isn't) Right for your project

June 04, 2020, 03:50 PM
Katie Mowery & Colton Turner Priority Designs & Priority Designs
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Remote Audits in a COVID-19 World

June 04, 2020, 04:45 PM
Taylor Brown & George Zack Greenlight Guru & Two Harbors Consulting
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Responding to the COVID-19 Pandemic: Scaling Up Operations When It Matters Most

June 04, 2020, 06:00 PM
Dan Purvis CEO, Velentium
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What we Learned from the Race to Supply the Market with Respirators, Masks, and other PPE

June 04, 2020, 06:55 PM
Todd Hillam Senior Scientist, Nelson Labs
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Practical Insights into Managing and Leading Medical Device Companies and Teams During the Pandemic

June 04, 2020, 07:50 PM
Amishi Vairagade Team Lead, Consultant, Azzur Group
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How to Navigate Raising Funds for Medtech Startups During a Pandemic

June 04, 2020, 08:45 PM
Paul Grand, Jeff Katz, Casey McGlynn & Dave Uffer MedTech Innovator, KPMG, Wilson Sonsini Goodrich & Rosati (WSGR) & Alira Health
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Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their Regulation

June 04, 2020, 09:55 PM
Allison Komiyama Principal Consultant, AcKnowledge Regulatory Strategies
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