Element RegNav’s Post

Check this out! Something we’ve been working on here at Element and leveraging our knowledge experts to help medical device development. Epic what the team have developed to help navigate and simplify the compliance journey to market. #medicaldevice #regnav #elementregnav #patientadvocates #regulatorycompliance

Exciting news to share with former medical device colleagues 📣👏🏼 Element Materials Technology just launched Element RegNav - a product that combines software, AI, and expert insights, streamlining safety and performance for medical devices. Learn more about this pioneering innovation by clicking the link ⬇️⬇️⬇️ #medicaldevices #digitalinnovation #makingtomorrowsaferthantoday

FDA is issuing this draft guidance to clarify how FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in FDA regulatory decision-making for medical devices. Read more! #IamUL

What is an adaptive #AI-driven medical device? In this new Med Device Online article, Jessica Chen and Thuha T. of San Jose State University define the term and provide an overview of the current FDA regulatory considerations for such devices. https://lnkd.in/esSBM2nQ #medicaldevices #medtech #artificialintelligence

Continuing our discussion last week on the FDA's new guidance for 506J FD&C Act in November of 2023. (Click to read below) https://lnkd.in/e_3hKRWi How do you think this will impact the efficiency of Medical Device companies? Let's discuss in the comments below. #MedTech #MedDevice #FDAGuidance #IndustryInsights #RA

🇪🇺 Ready to Enter the European Market with Your Medical Device? 🇪🇺 Navigating the EU's regulatory landscape for medical devices and in-vitro diagnostics can be complex—but it doesn't have to be. Check out our latest blog post, "Steps to Enter the European Market," for a complete guide on: ✔️Obtaining CE Marking ✔️Appointing a European Authorized Representative ✔️Registering with EUDAMED ✔️Identifying and registering an importer ✔️Maintaining ongoing compliance At OneGlobal Trinity M Consulting, LLC, we provide end-to-end support to ensure your product meets all regulatory requirements. Let us help you make your European market entry seamless! Read the full blog here ➡️ https://lnkd.in/eF4U9vei #trinitymconsulting #globalconsulting #medicaldevices #cemarking #eucompliance #regulatoryaffairs #mdr

Ever wondered whether a product with both a device and a drug is considered a medical device or something else? Head over to the blog to understand where these combination products fit and who regulates them. Part 2/n of "How Regulatory Approvals Shaped the Medical Device Industry." #medicaldevices #regulators #notifiedbody #combinationproducts #fda

📌 Regulatory Update for Medical Device Industry: FDA's Final Rule on Laboratory Developed Tests (LDTs) Now Effective   ↪ On May 6th, the FDA released a pivotal document, the "Final Rule Medical Devices; Laboratory Developed Tests," marking a transformative moment for the #medicaldevice sector. On July 5th, a turning point was achieved since this #FinalRule officially came into play.   🔍 Defining LDT: A Laboratory Developed Test \

🩺 Medical device manufacturers are facing the biggest EU regulatory shift in recent history. The MDR and IVDR are putting more pressure on MedTech companies with every device needing to be registered with and certified by the purpose-built European database of medical devices - EUDAMED. These new measures are excellent for improving the quality of the end product. Still, at the same time, they are threatening innovation, as organizations need to create increasingly complex documents faster. Find out how you can boost medical and in vitro device compliance with intelligent content in our new white paper. Read more here 👉 https://hubs.ly/Q02G0st60 #StructuredContent #ComponentContentManagementSystem #CCMS #StructuredContentAuthoring

🎓 Register for the free-to-attend introductory module of the course Medical Device Design & Development for New & Legacy Products taking place this September 2. During this introductory module, you will gain an overview of the Medical Device Regulation (MDR), compare the EU and FDA markets and explore device classifications and their implications for your product. #educolifesciences #mdr #legacyproducts #medicaldevicetraining