NAMSA

🌐 Enhance Your Publication Impact with NAMSA! 📚 Navigating through evolving regulations and increasing user demands requires transparency. Post-Market Surveillance findings and clinical study outcomes must be widely available and well-documented in clinical literature. Our skilled medical writers, with their deep industry knowledge, stand by to translate your clinical data into influential publications. Why Partner with NAMSA? 💡 Full-Service Support: We offer comprehensive assistance across various evidence communication formats, including Conference Abstracts, Systematic Reviews, Meta-Analyses, Clinical Manuscripts, Advisory Panel Presentations, White Papers, and more. ✨ Expert Data Interpretation: Our worldwide team of medical writers is adept at analyzing and conveying data, earning the trust of device manufacturers and regulatory bodies. 🚀 Dedicated Team Collaboration: Collaborating tightly with NAMSA's Regulatory, Clinical, and Biostatistics teams, we tailor our services to your specific needs and business goals. 🏆 Track Record of Excellence: Our Clinical Manuscripts have been featured in prestigious medical journals such as The Journal of Vascular Surgery, The Red Journal, and the Journal of Endovascular Therapy. Ready to Boost Your Clinical Publications? Let's build your publishing success together 🚀 https://lnkd.in/gBu7JpRr #ClinicalPublications #Manuscripts #MedicalWriting #NAMSAKnows

🎙️ In episode 7 of NAMSA's RAQA Café Podcast, we dive deep into the European Union (EU) In Vitro Diagnostic Regulation (IVDR). Join us as we sit down with Warren Jameson, NAMSA's Senior Manager of Regulatory and Quality, to explore the key aspects of IVDR 2017/746. We discuss the major changes compared to the EU's In Vitro Diagnostic Directive (IVDD), the impact on businesses of all sizes, and whether there has been a shift in the time it takes to get IVDs to market in the EU. Don't miss out on this insightful conversation, listen now: https://lnkd.in/g9EEg8hs #IVDR #RegulatoryCompliance #MedicalDevices

Check out our recently published piece on the significance of Electronic Data Capture (EDC) systems in clinical research trials. EDCs are software that electronically collect, manage, and store trial data, replacing traditional paper-based methods. The post explores how EDCs enhance data management and highlights their numerous benefits. Read the full post to discover how EDCs can streamline your processes and enhance data accuracy, efficiency, and security. Learn more here: https://lnkd.in/g7vBh5fU #ClinicalResearch #DataManagement #EDC

📢 NAMSA Blog: FDA's Regulation of AI/ML SaMD 📢 🚀Software is revolutionizing medical devices, from cloud platforms to clinical decision support. The rise of Software-as-a-Medical-Device (SaMD) is driven by healthcare digitization, rapid software development, and modern devices. Learn more about: 📋Navigating SaMD regulations, especially AI/ML-powered ones, presents challenges. The FDA ensures all medical devices, including SaMDs, meet safety and effectiveness standards. 📊AI/ML SaMDs use complex algorithms to analyze medical data and support decisions, requiring large, high-quality datasets and continuous monitoring to mitigate biases and ensure performance. 📈Discover how the FDA is advancing regulatory science for AI/ML SaMDs, including Good Machine Learning Practices (GMLP) and real-world evidence for ongoing validation. Read the full article here 👉 https://lnkd.in/gXrYk6fM #MedicalDevices #MachineLearning #HealthcareInnovation #NAMSAKnows #AIHealthcare #SaMD

The North American Biocompatibility Summit (NABS) is back in September 2024! 🎉 We would like to extend a huge thank you to our Sponsors for their support and contribution to this limited-seating event: ⭐ Eurofins EAG Laboratories (Presenting Sponsor) ⭐ LLS Rowiak LaserLabSolutions and Stantec (Silver Sponsors) ⭐ Labcorp (Bronze Sponsor) NABS provides invaluable industry insights and expertise sharing on the biocompatibility of medical devices. This year's sessions will cover: 📋 Regulatory updates 🔬 Biological evaluation strategies and best practices With the guidance of leading biological safety experts, attendees will learn about: 💡 New and innovative biocompatibility methods and technologies 🧪 Material/chemical characterization ⚠️ Toxicology 📉 Risk management 📚 Industry case studies Thank you again to all our Sponsors for helping make this event possible! #NABS2024 #biocompatibility #medicaldevices

Are you seeking a preclinical interventional and surgical laboratory with the experience, expertise, and cutting-edge equipment to conduct your medical device research efficiently and effectively? At NAMSA we are here to help ensure your success, with four global, state-of-the-art preclinical interventional and surgical facilities, NAMSA has the capabilities and experience to ensure the highest level of research success for your unique medical device testing requirements. Learn more about all of NAMSA's preclinical capabilities: https://lnkd.in/eDuYu7ZN Contact us today to learn how NAMSA can support your preclinical interventional and surgical program.

🎙️ Check out RAQA Café Podcast Ep. 13: Updates on the IVDR https://lnkd.in/gDnrNJXB Dive into the EU IVDR deadline extension with NAMSA's Christele Perrin-East and Warren Jameson. They share crucial insights on maintaining IVDR compliance and what the delay means for the industry. Christele advises, "If you count 12 or 18 months to get a technical file reviewed, you have to send your technical file like almost right now." Topics include: -The IVDR Extension -Lessons from the MDR -Impact on Existing Products Stay informed and prepared! 🔊💡 #IVDR #MedicalDevices #RAQAPodcast #RegulatoryAffairs #QualityAssurance

Join us at RAPS US Convergence, Sept 17-19, 2024, where we'll be at booth 931 ready to connect with you! Don't miss our very own Christele Perrin-East as she dives into the intricate world of diagnostics. Her talk, "LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?" is a must-see for anyone navigating the regulatory maze. 📅 Mark your calendars and be part of the conversation that shapes the future of medical device regulations. https://lnkd.in/gXeJX_AV #NAMSA #RAPS2024 #MedicalDevices #RegulatoryAffairs #ClinicalTrials

📢 Upcoming Webinar: AI/ML SaMDs Medical Devices: New and Unique Challenges in Getting to Market 📢 Join our webinar on the FDA approval process for Software as a Medical Device (SaMD). Learn from industry experts about SaMD-specific regulations and how to market your product effectively. Perfect for both startups and established firms, gain strategies to overcome typical hurdles in the digital health industry. 📅 Date: September 25th, 2024 🕙 Time: 10:00 AM - 11:00 AM CT Learning Points: 1️⃣ FDA's AI/ML Action Plan: ◾️Understand SaMD regulatory requirements. ◾️Overview of FDA's approach to SaMD regulation. 2️⃣ The Good Machine Learning Practices Model: ◾️Importance of clinical evidence for approval. ◾️Designing and conducting SaMD clinical studies. ◾️Required data and documentation for safety and efficacy. 3️⃣ SaMD Data Collection Challenges: ◾️Ensuring cybersecurity best practices. ◾️FDA expectations for data privacy. ◾️Implementing security for patient information protection. Speakers: Adam Saltman Principal Strategy Consultant, Clinical and Regulatory Services Monica Montanez MS RS RAC CQA Principal Strategy Consultant, Regulatory 🔗 Register https://lnkd.in/gyZZ_vYX Don't miss out on this opportunity to stay ahead in the competitive digital health landscape! #softwareasamedicaldevice #samd #artificialintelligencemachinelearning #aiml #NAMSAKnows

The North American Biocompatibility Summit (NABS) is back in September 2024! 🎉 We would like to extend a huge thank you to our Sponsors for their support and contribution to this limited-seating event: ⭐ Eurofins EAG Laboratories (Presenting Sponsor) ⭐ LLS Rowiak LaserLabSolutions and Stantec (Silver Sponsors) ⭐ Labcorp (Bronze Sponsor) NABS provides invaluable industry insights and expertise sharing on the biocompatibility of medical devices. This year's sessions will cover: 📋 Regulatory updates 🔬 Biological evaluation strategies and best practices With the guidance of leading biological safety experts, attendees will learn about: 💡 New and innovative biocompatibility methods and technologies 🧪 Material/chemical characterization ⚠️ Toxicology 📉 Risk management 📚 Industry case studies Thank you again to all our Sponsors for helping make this event possible! #NABS2024 #biocompatibility #medicaldevices