We're #hiring - we'd love it if you shared with your network! 🚀
Greenlight Guru
Software Development
Indianapolis, Indiana 21,924 followers
Moving MedTech Forward with our leading Quality Management System and Clinical Data Capture software
About us
Greenlight Guru is the #1 provider of modern cloud-based QMS & EDC 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
- Website
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https://www.greenlight.guru
External link for Greenlight Guru
- Industry
- Software Development
- Company size
- 201-500 employees
- Headquarters
- Indianapolis, Indiana
- Type
- Privately Held
- Founded
- 2013
- Specialties
- Medical Devices, Design Control, Regulatory Compliance, Quality Management, Risk Management, FDA 510(k), Document Control, QMS software, Quality Management System, ISO 13485, ISO 14971, FDA 21 CFR Part 820, FDA 21 CFR Part 11, Post-Market Surveillance, Quality System Regulations, Electronic Data Capture (EDC), ISO 14155, Clinical Data, Clinical Investigations, EDC System, and Clinical Data Capture Software
Locations
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Primary
601 S Meridian St
Suite 2H
Indianapolis, Indiana 46225, US
Employees at Greenlight Guru
Updates
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2024 brought massive regulatory shifts and exciting innovations in the MedTech world. 🌐 From FDA's Final Rule on QMSR to critical updates on EU IVDR timelines, it’s been a year of adaptation and progress. At Greenlight Guru, we stayed laser-focused on supporting MedTech professionals like you with actionable, timely content. 💡 Check out the most popular resources of 2024, including: ✅ Step-by-step guides on FDA submissions ✅ Insights on clinical data management ✅ Tools to navigate PMCF under EU MDR Plus, we’ve bundled our most in-demand templates, eBooks, and webinars into one easy download. 👉 Ready to level up your MedTech strategy? Dive into our top resources here: https://bit.ly/3Dgrn58 What was your biggest takeaway in 2024? We’d love to hear from you! 👇
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We're #hiring - we'd love it if you shared with your network! 🚀
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Are medical devices just about safety and effectiveness? 🤔 Ben Ettinger, Director of Product at Glassboard argues there's more to consider. He suggests learning from consumer product development to create desirable, joyful experiences in medical devices. Why? Because devices that stick around in the marketplace have a greater impact. By focusing on user experience, we can make the world better through products that people actually want to use. It's time to rethink medical device design. Safety first, but let's not forget the power of products that bring people joy. Want to see more of Ben’s insightful thoughts? Check out the full presentation “From Concept to Compliance: Aligning Stakeholders, User Needs, and Design Inputs” here 👉 https://bit.ly/3ZD6V6h
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We're #hiring - we'd love it if you shared with your network! 🚀
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Which conferences are you planning to attend in 2025? Attending the right conference can be a turning point for professionals in the medical device industry. These events offer opportunities to forge new partnerships, expand networks, and gain insights into the latest trends and regulatory updates. To help you plan your year, we've compiled a list of top medical device conferences in 2025: 1️⃣ LSI Emerging MedTech Summit USA: March 17-21 in Dana Point, CA. Brings together innovators, investors, and leaders to explore cutting-edge technologies shaping the future of healthcare. 2️⃣ J.P. Morgan Health Care Conference: January 13-16 in San Francisco, CA. This premier event connects global industry leaders, emerging companies, and investors. 3️⃣ 13th Annual Outsourcing in Clinical Trials: Medical Devices Europe: January 27-28 in Munich, Germany. A key event focusing on innovations and strategies in clinical trials and medical device development. 4️⃣ MD&M West: February 4-6 in Anaheim, CA. One of the largest gatherings of MedTech professionals in North America, showcasing innovations in medical device manufacturing. 5️⃣ Medical Technology UK: March 12-13 in Coventry, UK. Dedicated to the latest advancements in medical technology development and manufacturing. For a comprehensive list and more details, visit our blog: https://lnkd.in/e_53K24 Let us know where you're headed in 2025! 🙌
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How do you feel about your companies product development process for medical devices? In case you missed it, we have a webinar on that subject happening TODAY! The jump from stakeholder needs, user expectations, and design inputs is no easy task. It’s where innovation meets compliance—and where teams spend a lot of time spinning their wheels. Greenlight Guru's webinar will explore how to align these critical elements for smoother product development. What you'll learn: 1️⃣ Pinpoint needs: Separate stakeholder priorities from user requirements. 2️⃣ Align teams: Unite objectives for clearer paths forward. 3️⃣ Time it right: Know when to integrate design controls. 4️⃣ Turn needs into actions: Write precise, actionable design inputs. 5️⃣ Balance compliance and creativity: Foster innovation while staying audit-ready. Register to learn more! https://bit.ly/4fhMbqr Hope to see you at the webinar! #medicaldevices #medtech #greenlightguru
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We're #hiring - we'd love it if you shared with your network! 🚀
-
We're #hiring - we'd love it if you shared with your network! 🚀
-
We're #hiring - we'd love it if you shared with your network! 🚀