Greenlight Guru

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!

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! 🚀

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

Carrying out a supplier audit: when and how to audit your suppliers https://bit.ly/45W2XKE

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! 🚀

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

Turn your PMCF activities into a competitive advantage https://bit.ly/4eBfN3g

The regulatory landscape is evolving, but in very different ways across regions. In the US, the FDA is moving toward: -AI-supported, science-driven reviews -Streamlined triage and data analysis -Harmonization of 21 CFR Part 820 with ISO 13485 In the EU, the MDR continues to push: -Heavy clinical evidence requirements -Persistent Notified Body constraints With these changes, how are you feeling? Let us know in the poll and in the comments below.