June 2-4, 2020

The Greenlight Guru True Quality Virtual Summit

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device quality, regulatory, and product development professionals who drive innovation in the most well-respected, high-performing companies in the market today. 

Join an event unlike anything the medical device industry has seen before - streaming directly to your desktop, from the comfort of your own home - and learn how regulatory trends are evolving and the leading strategies, tactics, and best practices to conquer them. 

Taught by industry leaders who've taken medical device concepts through development, regulatory submission, and to market globally, within Fortune 500 companies and high growth startups.

The three-day, three-track event provides actionable takeaways you can implement in your own company to get devices to market faster, stay ahead of regulatory changes, and use quality as a strategic asset to grow your device business - despite all the challenges we're facing today.


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

An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Standard’s Working Group | Ed Bills, ASQ Fellow, RAC and Tom Rish

When to “Flip the Switch”- Balancing Late Feasibility and Early Design Controls | Jamison Float, Chad Gibson and Wade Schroeder

When to “Flip the Switch”- Balancing Late Feasibility and Early Design Controls | Jamison Float, Chad Gibson and Wade Schroeder

Design Considerations to Maximize Medical Device Cloud Connectivity | Keith Drake Ph.D. and Chris DuPont

Game Changing Product Definition Tactics | Scott Phillips

Medical Device Project Pitfalls and How to Avoid Them | Peter Sebelius

Why Design Validation is More Than Testing: How do we validate our validation? | Michael Drues

How User Experience Design and Human Factors Engineering can Accelerate Product Development | Miles Buroker and Milton Yarberry

Best Practices for Preparing and Conducting Pre-Submission Meetings | Isabella Schmitt, RAC

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

Economic Operators under EU MDR | onir El Azzouzi

Prioritizing Documentation for MDR Transition Planning | Evangeline Loh

Recent FDA feedback Regarding Extractable and Leachable (E&L) Testing and How to make sure FDA will accept your testing protocol | Matthew Jorgensen, Jesseca Lyons and Thor Rollins

IVDR Readiness Checklist | Taylor Brown and Oliver Eikenberg

Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive | Carolyn Guthrie

Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Marked, is that Device Safe and Effective? | Michael Drues

Strategies for ensuring a Medical Device released under EUA will stay on the market after EUA expires | Brad Graves and Cathy Wilburn

Navigating the 1 year EU MDR Extension | Chris Mauch

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

How to get your COVID-19 Related Medical Device to Market Under FDA Emergency Use Authorization (EUA) | Kyle Rose

Why Remote Research Is (or isn't) Right for your project | Katie Mowery and Colton Turner

Remote Audits in a COVID-19 World | Taylor Brown and George Zack

Responding to the COVID-19 Pandemic: Scaling Up Operations When It Matters Most | Dan Purvis

What we Learned from the Race to Supply the Market with Respirators, Masks, and other PPE | Todd Hillam

Practical Insights into Managing and Leading Medical Device Companies and Teams During the Pandemic | Amishi Vairagade

Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their Regulation | Allison Komiyama

Watch the Summit Series

GG_ST_Proxima CRO Webinar 12-15-22
Specifically, this summit series will cover:
  • Stay ahead of the ever-evolving changes and trends in the industry
  • Jumpstart your product development efforts and innovate faster
  • Move away from paper-based approaches and build a QMS that scales
  • Break down barriers by understanding the purpose and benefits of regulations and regulatory agencies
  • Easily get started in taking a digital-first approach to quality
  • Purposefully and consciously develop and deliver a quality product and data to meet the needs of those who benefit from the device
  • Create quality and regulatory processes that assure near real-time audit readiness
  • Advocate for shifting compliance-minded organizations to a True Quality focus
  • Gain resources that provide clarity through the uncertainty caused by the COVID-19 pandemic
  • Implement risk-based approaches and decision making
  • Build a culture of quality that accelerates clinical/regulatory approval
  • Think proactively about what new threats the medical device industry may have to address in the future
Who should attend? 
  • Medical Device Executives & Leadership Teams
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
Register Now  

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