Ketryx

As the volume of AI devices grows, maintaining rigorous software quality and managing updates will become even more critical. Read more in this insightful article from MedTech Dive, Elise Reuter and Jasmine Ye Han: https://lnkd.in/g8X2Nsxc We believe connected application lifecycle management tools are the path forward to ensure that AI software in these devices meets compliance standards, reduces error rates, and accelerates updates—all crucial as AI expands into broader medical specialties beyond radiology. With AI's potential to enhance diagnostics and efficiency, this growth in AI-enabled devices represents a valuable investment in the future of MedTech, driving innovation and better outcomes for patients. Where do you see AI driving the biggest changes in MedTech? #AI #MedTech #FDA #Innovation #Healthcare

Join us at our Regulatory Roundup on Nov. 13 at Arena, a PTC Business in the Seaport! Designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry, the agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts. Agenda highlights include: ⭐ A keynote from Keynote presentation from Dr. Michelle Tarver, Acting Director, CDRH, FDA ⭐ Moderated Q&A session with Dr. Michelle Tarver, facilitated by Veeva MedTech ⭐ Driving Value with the Adoption of AI in Healthcare QARA Systems, presented by IQVIA Technologies ⭐ Which MedTech Companies Will Survive the Coming PCCP Shakeout?, presented by Ketryx ⭐ Laboratory Developed Tests (LDT) and In Vitro Diagnostics as Regulated Medical Devices, presented by Ropes & Gray LLP ⭐ Accelerating Regulatory Approvals & Time to Market with AI-powered Clinical Data and Virtual Twins, presented by Dassault Systèmes ⭐ Insights Into The Development Of IEC 60601-1 4th Edition, presented by Intertek Space is limited! Register now: https://bit.ly/4cmSvML #medtech #regulatory #quality #compliance

Excited to speak at The MedTech Conference presented by AdvaMed on Wednesday, October 16th. My talk, "FDA-Grade AI: Total Product Lifecycle Control with a PCCP," will cover the integration of AI/ML in medical device manufacturing, the latest regulatory trends, and strategies for accelerating SaMD release cycles using a PCCP. Join us for an insightful session and visit us at Booth #1015 to learn how Ketryx is helping lead medtech companies improve patient outcomes by bringing validated software to market faster. #SoftwareRegulations #SaMDCompliance #FDACompliance #ITRegulations #FDARegulatoryGuidelines #ComplianceUpdates #SoftwareAudit #RegulatoryInsights #SoftwareCertification #SBOM #PCCP

🌟 We're excited to share Erez Kaminski’s experience at the 2024 Combination Products Summit presented by AFDO/RAPS Healthcare Products Collaborative in Providence! Engaging with industry leaders on AI, cloud computing, and the implications of the draft Predetermined Change Control Plan (PCCP) was insightful. These discussions are crucial as these technologies continue to shape the future of MedTech and drive innovation in combination products. Big thanks to Ryan Hoshi Ph.D., Ph.D., for the invitation and all who made it such a successful event! #MedTech #PCCP #AI #CloudComputing #Innovation #Compliance #CombinationProducts

Code reusability is a core benefit of a system-of-systems approach. It can significantly reduce the number of defects and improve on-time delivery. Check out this FREE webinar (no form) to learn more about achieving a systems-of-systems architecture for SaMD and AI/ML-enabled medical devices. Link is in the comments.

🚀 Discover how GitHub and GitLab can meet IEC 62304 standards, in Ketryx's latest webinar led by Danielle DeLatte, PhD, Director of Client Operations, and Milan Dzenovljanovic, Senior Software Developer. Learn how to: 🟢 Trace unit/automated tests from your Git repository to test cases and requirements 🟢 Manage design controls for multiple product versions 🟢 Implement essential engineering controls across your Total Product Lifecycle Join us and streamline your development processes. Register now for our October 31, 11 AM ET session! #git #github #gitlab #SoftwareTraceability #TraceabilitySolutions #TraceabilityTools #TraceabilityFramework #TraceabilityBestPractices #DevOpsTraceability #RequirementsTraceability #VersionTraceability #QualityAssurance #ReleaseManagement #SoftwareAuditTrail #SoftwareLifecycleTraceability #fdatraceability #TraceabilityManagement #EndToEndTraceability #AgileTraceability

Struggling with slow release cycles in MedTech? 🫤 Our CEO, Erez Kaminski, saw this firsthand while working in AI and biotech, which led him to start Ketryx. Discover how he and Jan Pöschko built a solution to help MedTech teams like yours speed up FDA-compliant software development, without sacrificing quality. Ketryx helps to enforce the processes you already have, in the tools you’re already using, generate evidence of compliance, and ship products faster. Learn more about how Ketryx began and how to decrease your release cycle time: https://lnkd.in/dvvJcUts

🚨 Only 2 days until our webinar, Jira for IEC 62304! Join Gabriel Pascualy and Jen Aceto from Ketryx this Thursday, October 3rd at 11 AM ET to explore common compliance gaps in Jira and learn integration strategies for medical device development workflows. Don’t miss the live demo and Q&A! Register now: https://lnkd.in/d4jG_iDy #MedTech #Compliance #Jira #SoftwareDevelopment #FDAApproval

Are you struggling to balance compliance with speed in MedTech software development? 🔍 Our white paper, "Delivering Compliant Software Faster with Validated DevOps," shows you how to align innovation with regulatory standards. Learn practical strategies to implement DevOps in a regulated environment, achieve faster release cycles, and maintain top-notch quality. Don’t let compliance slow down your progress—unlock the path to faster, compliant software development today. Get your copy here: https://lnkd.in/dBVpQVKf #MedTech #DevOps #SoftwareCompliance