Greenlight Guru

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Complex, software-intensive medical devices need many design iterations during development and frequent upgrades after product launch. How can rigorous risk management keep up with all those changes? If risk assessments are managed in documents (spreadsheets) then it will be very difficult, and in some cases impossible, to manually keep all the risk information and traceability up-to-date. Instead, a platform-based approach is needed where all the risk information and key design controls information are all managed together. This is an approach I call “Dynamic Risk Management” for efficient risk assessment and tracking of risk controls in an environment of frequent design changes. The most common approach I've seen to risk management (document-based) is quite static. This means that any changes to the product design require lots of editing to the risk documents. Product teams under time pressure are then tempted to wait until the product design stops changing before compiling the risk analysis documents (with all the drawbacks of that approach).  Don’t wait until the end of product development to perform risk analysis! In this article “Dynamic Risk Management for Software-Enabled Medical Devices” I explain: 🔷 The shortcomings of the document-based approach to risk management–why spreadsheets work well initially but not throughout the product life cycle 🔷 The basic mechanics of using the platform-based approach, with dedicated software tools (“The Hub”) to manage risks and risk controls  🔷 Integration of risk management with design controls in The Hub 🔷 Documentation automation to revise documents rapidly and efficiently https://lnkd.in/eRr9sVEh This is the fourth article in a series I co-authored with Monik Sheth, founder of Ultralight Labs (now part of Greenlight Guru) Development of complex, software-intensive medical devices requires iterative design and iterative design requires dynamic risk management.

Dynamic risk management for software-enabled medical devices https://bit.ly/45saNtz

“A computer in our AI system can really find these connections and these points that are fringe thoughts and ideas.” — Joshua Eckelberry, Solas BioVentures This quote hit home in our recent conversation on AI’s role in diagnostics. It's a powerful reminder that what may seem like noise or outliers to the human eye could be meaningful signals when processed by AI. From detecting subtle anomalies in cardiac and urinary biomarkers to uncovering overlooked patterns in clinical data — AI is not replacing clinicians; it’s amplifying them. 💡 Imagine what we’ll uncover when we trust AI to show us what we never thought to ask. Check out more of Etienne Nichols 🎙️ discussion with Joshua that offers an inside look at Solas BioVentures’ early-stage investment approach, emphasizing IP defensibility, hands-on support, and founder guidance while navigating today’s shifting venture capital landscape. You can see the full video here: https://bit.ly/47ew0cT #AIinHealthcare #DiagnosticsInnovation #MedicalDevices #SolasBioVentures #GreenlightGuru #MedTech

Bringing a software-enabled medical device to market is hard enough. Figuring out what FDA, EU MDR, and ISO 62304 require shouldn't slow you down. That’s exactly why we created The Ultimate Guide to Software as a Medical Device (SaMD) — a no-fluff, high-utility resource built to help early-stage teams move faster and with confidence. In this guide, you’ll learn how to: ✅ Determine if your product qualifies as SaMD or SiMD ✅ Understand classification differences (FDA vs. EU MDR) ✅ Cut through the noise on what documentation actually matters ✅ Navigate the evolving AI/ML landscape in medtech ✅ Prepare for postmarket surveillance and regulatory updates Whether you're in product, quality, or clinical, this is your shortcut to clarity. 👉 Link in comments #SaMD #MedTech #RegulatoryAffairs #MedicalDevices #GreenlightGuru #SoftwareAsAMedicalDevice #FDA #EUMDR #ISO62304 #AIinHealthcare

Happening tomorrow! Don’t miss a live taping of The Global Medical Device Podcast with Etienne Nichols of Greenlight Guru and Joshua Eckelberry from Solas BioVentures. They’ll unpack what MedTech investors are really looking for—plus the pitfalls to avoid and the trends you need to watch. 🎧 Tune in for real talk on funding success in MedTech. 📅 Save your spot: https://bit.ly/40FWyzY #MedTech #LifeSciences #VentureCapital #GreenlightGuru #MedicalDevice

We're #hiring - we'd love it if you shared with your network! 🚀

Join us for a special live taping of The Global Medical Device Podcast! Etienne Nichols 🎙️ of Greenlight Guru sits down with Joshua Eckelberry of Solas BioVentures to explore what MedTech investors really look for. From red flags to rising trends—don’t miss this insider look into funding success. You can register in the link below.

We’re excited to share that Greenlight Guru has acquired Enzyme, a modern QMS company trusted by life sciences leaders. This marks another step forward in our mission to help medtech and life sciences teams bring safe, effective products to market faster and with confidence. Welcome, Enzyme customers and employees! We’re glad you’re here. You can read more about the acquisition in a blog post from our CEO, Ed Holmes: https://bit.ly/44I83cq #GreenlightGuru #MedTech #EnzymeQMS #QualityManagement #LifeSciences