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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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FREE ON-DEMAND VIRTUAL SUMMIT:
December 8-9, 2020

2021 State of Medical Device True Quality Summit Series

How will COVID-19, new programs and regulatory changes on the horizon, as well as technological shifts and trends impact your medical device company in 2021?

With uncertainty still looming, what will it take to plan for the future, while staying flexible enough to quickly pivot when challenges are thrown your way?

The 2021 State of Medical Device Virtual Summit is for quality, regulatory, and product development professionals to understand the strategies, tactics and technologies being used today and uncover best practices, tips, and trends for the evolving nature of the industry.

The two day, digital event dives into perspectives, predictions, and experiences of industry leaders and takes a deep dive into the insightful findings from Greenlight Guru’s State of Medical Device Product Development and Quality Management Report.

Now's your chance to uncover what it takes for your company to move forward and succeed in 2021.

Sessions

Behind the Stats: 2021 Medical Device Product Development & Quality Management Benchmark Survey | Jon Speer and Nick Tippmann

The FDA Digital Health Center of Excellence and the Advancement of Digital Health Technology | Taylor Brown and Matthew Diamond MD, PhD

Impact of Brexit, Swixit, Turkxit for the European Medical Device Market | Monir El Azzouzi and Tom Rish

Audits: Let’s get back to Auditing, REMOTELY! | Nicolle Cannon and Karen Schuyler

FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will Change? | Michael Drues PhD and Wade Schroeder

Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements | John Lorenc, Barret Mueller and Gary Saner

Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond | Tom Rish and Andrew Wu

Strategies for Improving Medical Device Software and Cybersecurity | Chris DuPont, Christopher Gates, Pooja Kartik, Shane Keating and Cathy Wilburn

The Numbers: A Complete Re-Forecast of the Global Medical Device Market (2020-2025) | Scott Pantel and Nick Tippmann

A Delay in MDR: Where are We Now? | Thor Rollins and Karen Schuyler

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Specifically, this summit series will cover:
  • Looking to get ahead of the regulatory changes and trends coming in 2021
  • Ready to understand strategies, tactics, and technologies today’s medical device professionals are using to accelerate product development, ensure compliance, and promote quality
  • Forward-thinking, and recognize the importance of planning for the future, while staying flexible enough to pivot quickly
  • Wanting to learn what market-leading companies are doing to prepare for the future (and how your organization can do the same)
  • Facing uncertainty with the COVID-19 pandemic and looking for resources to provide clarity
  • Advocate for shifting compliance-minded organizations to a True Quality focus
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
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