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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

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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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:
September 21-24, 2021

Get to Market True Quality Summit Series

Whether you’re bringing your first device to market, or you have launched multiple already, our upcoming True Quality Summit Series is for you. There’s a variety of different topics designed to provide best practices for advancing throughout your product lifecycle and maintaining compliance across multiple markets.

Festivities kick off with a day dedicated exclusively to our customer community. From there, the True Quality Summit Series begins and anyone from anywhere can join, for free.

Sessions

What Role Should Quality Play in Bringing a Device to Market? | Jon Speer

Building the Business Case | John Kapitan

Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk | Abbas Dhilawala

Strategies to Limit Project Timeline and Cost in Medical Devices | Milton Yarberry

Building a Regulatory Strategy Executive Summary: How early in the development process should we begin to think regulatory? | Mike Drues

Developing a New Clinically Relevant ICU Ventilator Fast | John Walmsley

UDI and Device Registration, Another Launch Checkbox | Gary Saner

The Most Common Mistakes Health Tech Founders Make When Pitching | Adam Dakin

Company Essentials: The Benefits of a Well-Developed Regulatory Plan | Isabella Schmitt

How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch | Kyle Rose

So You Think You Want to go to Europe? Considerations for Early Adopters of MDR | Michelle Lott

Biocompatibility Evaluation for Device Submission | Audrey Turley

Design Control 101 | Justin Rowland

Market Access Strategy | Leslie Wise

Understanding the Medical Device Single Audit Program (MDSAP): Pros, Cons, and How to Prepare | Angelina Hakim

The Importance of Product Classification to Regulatory Strategy | Daryl Wisdahl

US FDA 101 | Carolyn Guthrie

Pre-Market vs. Post Market Risk: What are the similarities and differences? | Mike Drues

How to Successfully Plan a Medical Device Product Development Project | Peter Sebelius

Why You Need to Use IEC 62304 for Software Development | Cathy Wilburn

Tips for Working with Contract Manufacturing | Eddie Ray

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Specifically, this summit series will cover:
  • What it truly means to be quality focused (and how a quality culture can impact your specific company and your medical device)
  • How to tune your QMS to support your development process
  • How to design labeling to optimize your regulatory strategy
  • How to estimate regulatory risk and regulatory burden
  • Tips for improving your pitch deck slides with key elements that help increase your chances of gaining favor with health investors
  • How the design transfer records should be outlined and planned to ensure everything is documented along the way
  • Market case for FDA and EU commercialization and lessons from early adopters of MDR
  • How to understand medical device UDI requirements by region
  • Why it’s important to do design control activities in the right order (and how to integrate risk throughout the process)
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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