Greenlight Guru Academy

Greenlight Guru is the #1 provider of modern cloud-based solutions for the MedTech industry, helping companies bring life-changing products to market faster, more efficiently, and with less risk. Greenlight Guru’s MedTech Suite provides quality management, product development, and clinical data management solutions, along with high-quality training and education required to keep up with the rapidly changing industry regulations.

With Greenlight guru, teams are improving efficiency, speed, and quality in every aspect of their organization to get products to market faster and keep them on the market longer.

For more information, visit www.greenlight.guru.

JMI Equity

Greenlight Guru

🚨 📍 The True Quality Roadshow is back in 2024... Have you claimed your free ticket, yet? 👀

⌛ We can highly assure you they are bound to fly off the shelf, so don't ponder too long. It's a free event, and we're bringing industry experts to learn from and network with. Plus Happy Hour with snacks and drinks! What's not to like? 🤩

These shows are so appreciated and loved by MedTech professionals everywhere, that we can hardly wait to host you. 🔥

Remember that our first stop is Boston, March 14!!! We hope to meet you there or at any of our other shows later this year.

👉 Tell a friend and claim your free ticket, here 👉 https://bit.ly/3SI4YBP

#tqr2024 #truequalityroadshow #greenlightguru #boston #copehangen #austin #saltlakecity #medtech #events #freeticket #medicaldevices

💚 We are excited to highlight our customer today - Chelsea and Westminster Hospital NHS Foundation Trust, one of the top ranked and top performing hospital trusts in the UK. 🏥 

💉 In addition to treating over 300,000 patients each year, the Chelsea and Westminster hospital trust also delivers a wide portfolio of research studies which include commercial studies hosted at the hospital and trust-sponsored Investigator Initiated Studies.

📝 Like many others, the research team at Chelsea and Westminster used paper Case Report Forms (CRFs) and felt it was a nightmare. They couldn't wait to get off paper, and so they looked for an EDC system. 💻

🌠 The team chose Greenlight Guru Clinical, after having looked at several other EDCs on the market. Part of that decision came down to Greenlight Guru Clinical's intuitive design, ease of use and quick responsiveness during the buying process.

Results? 📊 The team now has a comprehensive clinical data solution for collecting, monitoring, and managing data from all of the studies. The feedback from both the internal team, site staff, and patients has been really positive and they will continue using Greenlight Guru in future studies. 💌

Learn more about their story, here: https://bit.ly/4bJUkmG

#customerstory #customers #medicaldevices #medtech #researchstudy #clinicaltrials #ggclinical #greenlightguru #successstory

🥁🥁 The fifth annual 2024 State of the MedTech Industry Report is here and we can finally share it with all of you!

This year we surveyed 500+ professionals working across the medical device industry to understand their approach to innovation, clinical studies, quality management, process improvement, and much more.

Here are a few key highlights covered in the full report:
📌  The outlook for 2024 is overwhelmingly positive
📌  There are several key areas for improvement in measuring quality efforts
📌  Navigating the complexity of regulatory compliance remains a significant challenge
 📌 Clinical activities are gaining significant priority in 2024
📌  Five strategies market leaders are doing differently and how you can adopt them

Head to this page to download the report: https://bit.ly/3wlOJ6b

#stateofmedtech #stateof2024 #medicaldevices #greenlightguru #medtech #report

🎙️📻  In this Global Medical Device Podcast episode, Etienne Nichols and guest Ashkon Rasooli, Director Quality Management Sytems at Big Health, explore the transformative impact of AI in the medical device industry.

The discussion touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends.

Tune in now: https://bit.ly/49esFJ3.

#podcast #greenlightguru #medicaldevicepodcast #medicaldevices #medtech #ai #artificialintelligence

Not long ago, we collaborated with Helene Quie, CEO of Qmed Consulting A/S, on an article about how to best navigate clinical evaluations and investigations in Medtech. 

With over 25 years of experience in MedTech, Helene shares invaluable insights on:
📌  The importance of demonstrating compliance and presenting robust clinical evidence.
📌  Common challenges like detailed data analysis and consistent documentation.
📌  The underutilized role of post-market surveillance data.
📌  Bridging gaps between clinical objectives and investigative data.
📌  Best practices for defining outcome parameters and maintaining a dynamic regulatory pathway.

👉 Check the article out, and download the highly requested Q&A from Aligning Your Clinical Claims webinar with Helene, here:
https://bit.ly/49t7ToK

#medtech #medicaldevices #clinicalevaluation #clinicalinvestigation #clinicaltrials #greenlightguru #ggclinical

🚀 [SAVE THE DATE] Join our upcoming 2024 State of MedTech Summit Series between February 20-22. 🗓️
 
💡 This summit brings to life the most important insights from Greenlight Guru's latest 2024 State of the MedTech Industry Report.

💼 🔍 Based on insights from 500+ industry leaders, the summit will unveil evolving trends, strategic shifts, and critical challenges in the MedTech landscape.

👉 Save your seat here: https://bit.ly/3HWUNEr

#stateof2024 #stateofmedtech #greenlightguru #medicaldevices #webinars #medtech

We're #hiring a new Sales Development Representative in Denmark. Apply today or share this post with your network.

Being granted FDA Breakthrough Designation may open new doors, but with changes in coverage, what’s the real ROI?

In this #LSIUSA24 panel, we’ll hear from innovators, attorney’s, and regulatory experts who have navigated the strategic and operational challenges with winning FDA Breakthrough Designation.

The panelists will also evaluate changes brought on by TCET, and what to expect from a policy standpoint down the line.

We’ll hear perspectives from:

• Etienne Nichols (Moderator), Sr. Marketing Manager and Medical Device Guru at Greenlight Guru, which provides companies with industry-leading software and training to scale faster, become more efficient, and reduce risk throughout the product lifecycle.

• Kwame Ulmer, Managing Partner at MedTech Impact Partners (MIP). MIP helps companies navigate the FDA to bring medical technologies to patients faster. Kwame spent 12 years at the U.S. Food and Drug Administration in progressive leadership roles, including Deputy Director and Branch Chief.

• Carolina Aguilar is Co-Founder & CEO of INBRAIN Neuroelectronics, who was recently granted FDA Breakthrough Device Designation in September 2023.

• Nathan Beaver, Partner at Foley & Lardner LLP, is a seasoned FDA attorney with expertise in Hatch-Waxman pharmaceutical issues, devices, biologics, foods and dietary supplements, and cosmetics.

• Lishan Aklog, MD is Chairman & CEO at Lucid Diagnostics, who was granted FDA Breakthrough Device Designation in 2020.

We are still accepting registrations for LSI USA ‘24 on March 18-22 in Dana Point, California. Visit our website to learn more and secure your spot.

In the US, there are three independent but also interdependent systems to categorize the risk a medical device poses:

❗ Classification system (I, II, III),
❗ software documentation level (A, B, C),
❗ and seldom talked about risk system is the Significant Risk (SR) or Nonsignificant Risk (NSR) system.

📚 There is plenty of information available on the classification and software risk systems as well as SR devices. However, there is much less available on how to handle an NSR device.

🤔 Given that the vast majority of devices are NSR, what is a manufacturer of a NSR device to do?

Register for this webinar, presented by regulatory expert Michael Drues, to learn best practices to avoid timely and costly mistakes as well as creative ways to use the SR vs. NSR system to your advantage!

👉 https://bit.ly/42xP9C9

#livewebinar #webinars #greenlightguru #significantrisk #nonsignificantrisk #medicaldevices #medtech

🤯❗ FDA has published the final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016.

💥 The final rule also changes the title of 21 CFR Part 820 from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR). In other words, we're saying goodbye QSR and welcoming in a 2-year transition period, as the QMSR comes in effect on Feb 2, 2026.

🤔 While this seems like a long time, it's always best to start thinking early about how you'll comply with QMSR.

💡👀 And if you’re concerned about what this means for your business, your QMS, and your devices, don’t worry. We’re covering everything you need to know in this article.

👉 Check it out, now: https://bit.ly/485G6tA

#medicaldevices #fda #qmsr #qsr #qualitymanagement #21cfrpart820 #iso13485 #medtech #greenlightguru

ETQ Reliance QMS is a quality management system that provides comprehensive solutions for compliance and risk management.

ETQ Reliance QMS

Arena PLM & QMS offers product lifecycle management and quality management solutions for various industries.

Arena PLM & QMS

Qualio is a quality management system designed for life sciences and other regulated industries.

Qualio

MasterControl Quality Management System provides solutions for document control, training management, and other quality processes.

MasterControl Quality Management System

Apryse Software provides document processing tools and solutions for various industries.

Apryse

Axiom EPM offers enterprise performance management solutions for financial planning and reporting.

Axiom EPM

Solidatus provides data lineage and metadata management solutions for organizations.

Solidatus

Tecplot offers visualization and analysis software for computational fluid dynamics and numerical simulation data.

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AssurX provides quality management and regulatory compliance solutions for various industries.

AssurX

Omnex, Inc. offers consulting and training services for quality, environmental, and safety management systems.

Omnex, Inc.

Greenlight Guru provides innovative solutions and industry expertise to help move MedTech forward by improving the quality of life for customers and their patients. They offer a powerful, intuitive solution for medical device companies to bring higher quality, life-changing products to market faster, more efficiently, and with less risk.

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