Ketryx

How can pharma teams validate AI in GxP environments—while accelerating innovation? AI has already enabled breakthroughs in personalized medicine, clinical trials, pharmacovigilance, and manufacturing. But when it comes to compliance, most pharma and biotech teams are still trying to validate AI models with tools built for deterministic software. This results in slower innovation, compliance gaps, and risky audit trails. Join Erez Kaminski, former head of AI at Amgen, and Gabriel Pascualy, former leader in Quality/Reliability for AI at Amgen, on Tuesday, April 22 at 11 AM ET for an expert-led webinar where you’ll learn: ✅ A step-by-step framework for AI validation in GxP-regulated environments ✅ Risk-based approaches to managing AI bias, explainability, and traceability ✅ Tools and automation strategies to streamline validation and regulatory approval ✅ How to align AI governance with FDA, EMA, and evolving compliance standards If you’re working on AI in pharma or biotech, this is a must-attend! #Pharma #AIValidation #GxP #Compliance #LLM #Biotech #Regulatory #Ketryx

User interface and labeling continue to play an important role in the FDA’s new draft guidance on AI-enabled medical devices. In this clip from our recent webinar, Jenn Dixon, P.Eng was joined by Eric Henry, Senior Quality & Regulatory Compliance Advisor at King & Spalding, to unpack: 👁️ Why user interface and labeling for AI systems is an important part of the FDA’s January 2025 draft guidance 📘 How labeling contextualizes what the device is all about - i.e. what is the interface? What do you want the user to do? If you are a medical device manufacturer, this is a section you can't overlook. Watch the full webinar for a deeper dive into learning about strategies for aligning IEC 62304-compliant quality management systems to the FDA’s new draft guidance. Check out the full webinar in the comments below. #MedTech #AIinHealthcare #FDACompliance #MedicalDevices #DigitalHealth #RegulatoryStrategy #Ketryx

Healthcare is definitely a standout industry as it is ripe for disruption and there are so many companies getting funded. On VentureFizz, we've compiled a list of healthcare companies who are hiring. You'll find: Manifold, Zus Health, VideaHealth, Veeva Systems, OM1, Inc., NuvoAir Medical, Goddard, Nayya, LightForce, Lexington Medical, Inc, Kyruus Health, Imprivata, HealthEdge, Cohere Health, Chewy, Cedar, Bamboo Health, Aspen Technology, Linus Health, Assured Allies, Ketryx, PatientPoint®, Amwell, 1upHealth, Inc., WHOOP https://lnkd.in/eJGF5akm

Leading companies are already using predetermined change control plans (PCCPs) to bring AI and ML-powered devices to market. Our PCCP guide and template can help you navigate compliance requirements with confidence. Learn more here: https://lnkd.in/dHJCc9pv

Git is essential to modern development—but repositories weren’t built to support IEC 62304 traceability or total product lifecycle control for medical device software. So how do you close the gaps? Back by popular demand, this re-broadcast of our most popular webinar will show you how to create end-to-end traceability from unit and automated tests to test cases and requirements and more. We’ll walk through each major section of 62304, highlight common challenges in regulated software development, and offer practical solutions—plus, a team member will be live to answer questions and give real-time demonstrations.

We're #hiring a new Front-End Software Engineer in Vienna, Vienna. Apply today or share this post with your network.

We're #hiring a new Account Executive in Boston, Massachusetts. Apply today or share this post with your network.

Trying to bring agile into your IEC 62304-compliant development but hitting roadblocks? You’re not alone. 📘 Our new eBook shows how to structure Jira for compliance—without disrupting your workflow. #IEC62304 #Jira #AgileDevelopment #MedTech #Compliance #SaMD #Ketryx

MedTech Dive and Elise Reuter published a great piece on the importance of Predetermined Change Control Plans (PCCPs) for medical device software — and we’re thrilled to see our customer Beacon Biosignals featured. Beacon received FDA authorization for two PCCPs in 2024. Behind the scenes, they’ve been using Ketryx to power their development and compliance processes and have achieved amazing results. ✅ 50% reduction in release cycle time ✅ 75% reduction in documentation cycle time ✅ Fully traceable, audit-ready software development At Ketryx, we’re proud to support teams like Beacon as they push the boundaries of what’s possible in healthcare. Their success is a great example of how the right infrastructure can accelerate both innovation and regulatory confidence. Check out the article below and our case study with Beacon Biosignals in the comments. #MedTech #FDA #PCCP #AIinHealthcare #MedicalDevices #SoftwareValidation #DigitalHealth

We’re excited to welcome Danielle Rejwan (Lavi) to the Ketryx team! 🎉 Fun fact: Not only is Danielle bringing her expertise to the team, but she’s also a professional jazz and hip-hop dancer! 💃 Here’s to new beginnings and big things ahead — welcome to the team, Danielle! 🌟