We're #hiring - we'd love it if you shared with your network! 🚀
Greenlight Guru
Software Development
Indianapolis, Indiana 23,329 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
Get directions
601 S Meridian St
Suite 2H
Indianapolis, Indiana 46225, US
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Get directions
K Christensens Vej
Aalborg, North Denmark Region 9200, DK
Employees at Greenlight Guru
Updates
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Greenlight Guru reposted this
Simplifying the Medical Device path to market | Connecting people, processes, and tools to build better MedTech | QMS, EDC, & Design Controls software 📈
Have you ever thought about the actual people behind the clinical data? In clinical research, we’re usually a bit removed from the people at the heart of it all - the study participants. But really understanding what they're experiencing, and will experience in the study, is really valuable. It's called "empathy," and it's considered a "soft skill." Soft skills have historically been de-valued by much of the STEM world. (That's all going to change with the introduction of AIs, but I digress...) It turns out a little empathy can positively impact clinical studies. Which is why we're putting on a webinar with Megan Lamberti from Nilo Medical Consulting Group called "Compassion and compliance in the conduct of clinical research." We'll be discussing how to: 💥 Build better trials using compassionate design principles. 💥 Build trust between researchers, coordinators, and site staff. 💥 Improve regulatory engagement through empathic communication. If you're in clinical ops, regulatory affairs, or leading cross-functional research teams, this is gonna be good! Wow, almost forgot... it's tomorrow, July 17th at 12:00pm EST! Here's the 🔗: https://lnkd.in/euP2pNt4 Hope to see you there!
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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! 🚀
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Greenlight Guru reposted this
Join our founder, Staci Miller for a free live Greenlight Guru webinar today at 3:30pm ET: “Mastering the Design History File: What to Include, Why it Matters, and How to Avoid Mistakes.” Register now to save your spot: https://hubs.ly/Q03wFQ4B0 #DesignHistoryFile #GenUXConsulting #GreenlightGuru #DHF #HumanFactors #UXResearch
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Carrying out a supplier audit: when and how to audit your suppliers https://bit.ly/45W2XKE
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We're #hiring - we'd love it if you shared with your network! 🚀
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We're #hiring - we'd love it if you shared with your network! 🚀
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Mastering the Design History File: What to Include, Why It Matters, and How to Avoid Mistakes Design History Files (DHFs) are often treated as a regulatory checkbox—but they can be a powerful tool for protecting usability, design intent, and product quality. Join us this Thursday from 3:30-5 PM ET for a webinar featuring Staci Miller from GenUX Consulting. We’ll dive into how well-organized, complete Design History Files (DHFs) do more than meet regulatory requirements—they help reduce risk, support better design decisions, and pave the way for smoother audits, validations, and acquisitions. We'll cover: -What belongs in a DHF for human factors and why it matters -How strong DHFs align with FDA and ISO usability requirements -Common documentation gaps that derail research and validation -How great DHFs streamline handoffs, audits, and growth opportunities This session is built for product, clinical, quality, and regulatory teams who want to get it right the first time and every time after. Register here 👉 https://bit.ly/4eypOhu #MedTech #HumanFactors #UsabilityEngineering #DesignControls #MedicalDevices #QualitySystems #GreenlightGuru
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Turn your PMCF activities into a competitive advantage https://bit.ly/4eBfN3g