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MonJun 6
7 : 00 AM
Mon Jun 6
7 : 00 AM - 5 : 30 PM

Green Carpet Day (Greenlight Guru Users Only)

We're rolling out the Green Carpet for an event dedicated exclusively to our customer community.

The day kicks off with Breakfast and is packed full of keynotes, customer-driven panels, sneak peeks of our upcoming releases, and training sessions to take your Greenlight Guru usage to the next level.

The schedule below is subject to change!

Green Carpet Day
8 : 00 AM
Mon Jun 6
8 : 00 AM - 9 : 30 AM

Green Carpet Day Opening Keynote

Hear about the State of Greenlight Guru, Product Roadmap, Multi-Year Vision and how it relates to you - our customers!
Green Carpet Day
9 : 30 AM
Mon Jun 6
9 : 30 AM - 10 : 00 AM

Networking Break

Green Carpet Day
10 : 00 AM
Mon Jun 6
10 : 00 AM - 10 : 30 AM

All about timing: Design Controls, Risk, and more

[Breakout session]

When to get started with design and development and why it matters

Green Carpet Day
Mon Jun 6
10 : 00 AM - 10 : 30 AM

All about timing: CAPA, Audit, and more

[Breakout session]

When to get started with establishing quality processes and why it matters

Green Carpet Day
11 : 00 AM
Mon Jun 6
11 : 00 AM - 11 : 30 AM

Product Showcases

[Breakout session]

Join us as we highlight the new developments and upcoming features of Greenlight Guru's software. 

Green Carpet Day
11 : 30 AM
Mon Jun 6
11 : 30 AM - 12 : 30 PM

Design Control 101

[Hands-on Training]         [By Device Type]

How to document your design with Greenlight Guru to drive efficient, risk-based product development that fuels the success of your entire project.

Green Carpet Day
Mon Jun 6
11 : 30 AM - 12 : 30 PM

Automation 101

[Hands-on Training]

Learn the power of automating your quality event workflows with Greenlight Guru.

Green Carpet Day
12 : 30 PM
Mon Jun 6
12 : 30 PM - 2 : 00 PM

Lunch

Green Carpet Day
2 : 00 PM
Mon Jun 6
2 : 00 PM - 3 : 00 PM

Survey Says: Achieving CAPA Excellence

[Breakout session]

Nearly half of companies rate their company’s level of competence with CAPA as average or below. And just 17% of companies feel they have achieved excellence as it relates to their CAPA process. Dive into these findings with peers and discuss ways to level up your CAPA competency.

Green Carpet Day
Mon Jun 6
2 : 00 PM - 3 : 00 PM

Survey Says: Keeping up with Innovation and Technology

[Breakout session]

With 8 in 10 MedTech companies are predicting growth for 2022 and 54% are investing in advanced technologies for their products, there is a new wave of tech driving growth and innovation in the industry. Dive into these findings with peers and discuss how to balance these pressures of innovation and growth in the industry. 

Green Carpet Day
3 : 00 PM
Mon Jun 6
3 : 00 PM - 3 : 30 PM

Building your BOM: Medical Device Product Management

[Hands-on training]

How to manage your product development work with Greenlight Guru, when to get started, best practices, and the importance of DMR documentation.

Green Carpet Day
Mon Jun 6
3 : 00 PM - 3 : 30 PM

Top 10 Tips & Tricks for using GG

[Hands-on training]

To be the best, you need to use GG the best! Our product experts will share little-known tips and tricks to level up your use of the Greenlight Guru software.

Green Carpet Day
4 : 00 PM
Mon Jun 6
4 : 00 PM - 4 : 30 PM

Networking break

Green Carpet Day
4 : 30 PM
Mon Jun 6
4 : 30 PM - 5 : 30 PM

Closing Keynote & Awards

Don’t miss this fun close of the day as we celebrate our customer community.

Green Carpet Day
6 : 00 PM
Mon Jun 6
6 : 00 PM - 8 : 00 PM

True Quality 2022 Welcome Reception

We're excited to welcome you to sunny San Diego! Greenlight Guru customers, event sponsors, speakers, and all True Quality registrants are invited to our opening reception. Enjoy networking, drinks, and hors d'oeuvres and get ready for what's to come. 

True Quality
TueJun 7
7 : 00 AM
Tue Jun 7
7 : 00 AM - 8 : 00 AM

Registration Open & Breakfast

Join us in Paradise Foyer to get your conference badge and bag, and then head over to Paradise Terrace for breakfast.
True Quality
8 : 00 AM
Tue Jun 7
8 : 00 AM - 8 : 15 AM

Opening Remarks

True Quality
8 : 15 AM
Tue Jun 7
8 : 15 AM - 9 : 00 AM

Behind the Research: Overcoming the Barriers to Improved Quality

[Keynote] Presented by Sandra Rodriguez | Senior Industry Analyst - Axendia, Inc.

New market research reveals 87% of executives admitted to having an ineffective requirements management process. Additionally, products rarely launch by target release date; and, never get delivered at or below original budget! How can quality help accelerate the success of your product? Join the keynote for more eye-opening results.

True Quality
9 : 00 AM
Tue Jun 7
9 : 00 AM - 10 : 00 AM

The New Era of MedTech

[Keynote] Presented by David DeRam, CEO Greenlight Guru
True Quality
10 : 00 AM
Tue Jun 7
10 : 00 AM - 10 : 15 AM

Networking Break

True Quality
10 : 15 AM
Tue Jun 7
10 : 15 AM - 10 : 45 AM

Mastering your Mindset

Presented by Kevin Bailey, CEO & Founder | DreamFuel
True Quality
10 : 45 AM
Tue Jun 7
10 : 45 AM - 11 : 45 AM

The Future of Health & Medicine: Where Can Technology Take Us?

[Keynote] Presented by Dr. Daniel Kraft, Founder & Chair, Exponential Medicine
True Quality
11 : 45 AM
Tue Jun 7
11 : 45 AM - 1 : 15 PM

Lunch & Networking

True Quality
1 : 15 PM
Tue Jun 7
1 : 15 PM - 2 : 00 PM

Building Companies & Careers: Your Brand

[Keynote] Presented by Joe Mullings, the Chairman and CEO of The Mullings Group Companies
True Quality
2 : 00 PM
Tue Jun 7
2 : 00 PM - 2 : 45 PM

Concept to Commercialization: Challenges, Lessons, and Triumphs in Bringing New Devices to Market

A panel of CEOs discusses the process of moving a complex medical device from “successful science project” into design and development, through regulatory hurdles, and into commercialization.

Panel with: Dan Purvis, CEO at Velentium | Molly Wade, CEO at Baralogics | & More

True Quality
Tue Jun 7
2 : 00 PM - 2 : 45 PM

Best Quality Practices for SaMD, including Artificial Intelligence and Machine Learning

A panel of SaMD experts will explore in detail developments in regulating AI-based devices and share the latest updates, as well as bold predictions for SaMD, AI/ML innovation and regulation in 2022 and beyond.

Panel with: Kyle Rose, President at Rook Quality Systems | Andrew Wu, Software Consultant at Rook Quality Systems | & More
True Quality
Tue Jun 7
2 : 00 PM - 2 : 45 PM

Understanding the critical interdependence of Risk with Pre- and Post-Market Activities

This presentation will discuss how to incorporate risk management activities into the QMS to ensure these feedback loops are triggered at the appropriate times, and appropriate actions are taken.

Presented by: Carolyn Guthrie, Director of QA/RA at Kapstone Medical

True Quality
2 : 45 PM
Tue Jun 7
2 : 45 PM - 3 : 30 PM

Status of EU MDR and EU IVDR after 5Y of Publication

It's been 5 years since the publication of the EU Regulations on medical and in-vitro diagnostic devices. Let's dive into the status of the implementation and discuss what we've learned over this time.

Presented by: Bassil Akra, CEO at Akra Team (Former VP at TÜV SÜD)

True Quality
Tue Jun 7
2 : 45 PM - 3 : 30 PM

Communicating With FDA: Is FDA hearing what you're saying? Are you sure?

In this workshop, participants will learn best practices for approaching – and communicating with – the FDA, specifically what, when and how.  Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive workshop.

Presented by: Michael Drues, Ph.D at Vascular Sciences

True Quality
Tue Jun 7
2 : 45 PM - 3 : 30 PM

Governance of cybersecurity program for developing medical devices

Join cybersecurity experts for a lively discussion about all things medical device cybersecurity, including mapping security activities and artifacts into existing lifecycle processes, using quality management to drive adoption, customer expectations, your own business interests, and more!

Panel with: Christopher Gates, Director of Product Security at Velentium | Abbas Dhilawala, CTO at Galen Data | & More

True Quality
3 : 30 PM
Tue Jun 7
3 : 30 PM - 4 : 15 PM

Regulatory Pathways and your Go-To-Market Strategy

During this session, you’ll learn about the nuances, similarities, and differences of regulatory pathways in the US, EU, and other markets. Discover how timelines, costs, and other considerations can affect the complex questions of which markets to pursue and when to make your move. 

Panel with: Michelle Lott, Regulatory Strategist, Principal and Founder - Lean RAQA | Damini Agarwal Director of Product Development - Infinite Biomedical | Isabella Schmitt, Director of Regulatory Affairs - Proxima Clinical Research

True Quality
Tue Jun 7
3 : 30 PM - 4 : 15 PM

MedTech Companies Will Never be the Same: A Quality Leader's Perspective

Details coming soon. 

Panel with: Mitch Lewandowski, Vice President, Quality - GRAIL | Amit Relia, Sr. Director, Quality - iRhythm Technologies | Patricia Setti-LaPerch, Director of Regulatory Compliance & Quality - Koios 

True Quality
Tue Jun 7
3 : 30 PM - 4 : 15 PM

Is Your Use Related Risk Analysis Half Empty or Half Full?

Details coming soon

Presented by: MaryBeth Privitera, Principal- Human Factors & Research at HS Design, Inc

True Quality
4 : 15 PM
Tue Jun 7
4 : 15 PM - 4 : 30 PM

Afternoon Break

True Quality
4 : 30 PM
Tue Jun 7
4 : 30 PM - 5 : 15 PM

CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond

Details Coming Soon
True Quality
5 : 15 PM
Tue Jun 7
5 : 15 PM - 6 : 00 PM

Fireside Chat with a Medtech Living Legend

Join us for a fireside chat with Dr. Manny Villafaña, Medtech entrepreneur and industry icon. Hear stories of how he has launched, expanded, and sold Medtech startups, including his most notable: Cardiac Pacemakers Inc. (CPI) and St. Jude Medical. We'll also learn about his newest company, Medical 21 who is on a mission to make heart bypass surgery safer, less painful, more accessible, and less expensive by eliminating the need for vessel harvesting.


Manny Villafaña has a substantial track record of founding companies that develop and deliver successful medical products to the healthcare market. Medical 21 is Manny’s eighth medical device company, and he has led his previous seven companies to an IPO financing.

As the founder of Cardiac Pacemaker, Inc. (CPI)/Guidant, he co-invented the first long-life lithium-powered pacemakers and defibrillators which revolutionized the pacemaker industry. The technology he developed in 1972 is still in use in virtually every defibrillator and pacemaker worldwide. CPI was purchased by Boston Scientific for $27 billion. He was the founder of St. Jude Medical, Inc and the co-developer of the St. Jude heart valve – an innovative mechanical bi-leaflet heart valve that dramatically reduced the frequency of blood clots. This is the most commonly used prosthesis in the world, in approximately five million patients. St. Jude was purchased by Abbott Laboratories for $30 billion.

Manny went on to develop several other companies including ATS Medical, which introduced the new generation ATS open-pivot heart valve. ATS was purchased by Medtronic for $400 million.

True Quality
7 : 30 PM
Tue Jun 7
7 : 30 PM - 10 : 30 PM

TQ After Dark

Party like a quality rockstar at True Quality After Dark! We're headed to the San Diego Air & Space Museum for an unforgettable night and celebration of the innovative work that you do every day. We will bring the surprise entertainment, delicious food and drinks, and memorable activities - you just bring the party! Get ready for a night to remember with your newest connections.
True Quality
WedJun 8
7 : 00 AM
Wed Jun 8
7 : 00 AM - 8 : 00 AM

Registration Open & Breakfast

True Quality
8 : 00 AM
Wed Jun 8
8 : 00 AM - 9 : 00 AM

Opening Remarks & Keynote

Details Coming Soon
True Quality
9 : 00 AM
Wed Jun 8
9 : 00 AM - 9 : 45 AM

Roundtable on EU MDR

Details Coming Soon
True Quality
9 : 45 AM
Wed Jun 8
9 : 45 AM - 10 : 15 AM

Networking Break

True Quality
10 : 15 AM
Wed Jun 8
10 : 15 AM - 11 : 00 AM

This is not your grandmother's validated state!

As engineers, regulators, and scientists, we need to adapt to a new set of software architectural approaches, best practices, and systems thinking, embracing a more modern approach to device safety and the meaning of the validated state. Join this presentation to learn how!
 
Presented by: Brett Stewart, Principal Solutions Architect - Orthogonal

True Quality
Wed Jun 8
10 : 15 AM - 11 : 00 AM

Into the Unknown: A look at where your file goes when you send it off to FDA

Listen as medical device professionals like yourself describe their product submission experience with FDA. Then, get a look into the world of FDA as two former FDA officials describe what happens when they get a submission. Don’t miss this peek behind the curtain!

Presented by: Allison Komiyama, Principal Consultant at RQM+ | Kate Dilligan, CEO at Cooler Heads | Michael Nilo, President and Principal Consultant at Nilo Medical Consulting

True Quality
Wed Jun 8
10 : 15 AM - 11 : 00 AM

The Wait is Over: Assessing the Proposed Rule Aligning FDA’s Medical Device Quality System Regulation with ISO 13485:2016

This session will discuss the notable changes in the proposed Quality Management System Regulation (QMSR), the most current expectations regarding how and when the rule will be finalized and implemented, and how it will impact both industry and the FDA itself. Even firms already certified to ISO 13485:2016 will have to make adjustments to their quality systems, so don’t miss this critical update.

Presented by: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice - King & Spalding

True Quality
11 : 00 AM
Wed Jun 8
11 : 00 AM - 11 : 45 AM

How NFTs will change Medtech

Details Coming Soon

Presented by: Omar M. Khateeb, Head of State & Host at  The State of MedTech | Henry Peck, Director of Global Marketing at Altoida 

True Quality
Wed Jun 8
11 : 00 AM - 11 : 45 AM

The Journey Continues: What to Know for US FDA Class I and other Global Regulator Requirements

The journey of UDI continues as mile markers for US FDA Class I, EU EUDAMED, China NMPA, South Korea MFDS and other global health regulators appear on the horizon. Learn more about UDI data management and submission experiences from the experts at Reed Tech. Hear about requirements and exceptions pertaining to UDI product data submissions and device label requirements.

Presented by: Gary Saner, Sr Mgr, Information Solutions-Life Sciences at Reed Tech

True Quality
Wed Jun 8
11 : 00 AM - 11 : 45 AM

Implementation of Risk Management Board for New Product Introduction & PMS

No medical device ever marketed has done so without some level of risk. ISO 14971 2019 and TR 24971 2019 provide the framework for the Risk Management Program. Once this framework is established, how is it implemented? Who are the stakeholders? Who provides the input? The session will attempt to answer these questions and many more and define Critical Success Factors for the process.  

Presented by: Mike Baca, White Rook Consulting (Formerly VP at Stryker, VP at Medtronic, & Senior Director at Johnson & Johnson)

True Quality
11 : 45 AM
Wed Jun 8
11 : 45 AM - 1 : 00 PM

Lunch & Closing Keynote

True Quality
1 : 00 PM
Wed Jun 8
1 : 00 PM - 2 : 00 PM

Networking in Exhibit Area & End of Conference

True Quality