NAMSA

🌍 NAMSA is proud to announce that we are sending 9 representatives from across the US, France, and the UK to the ISO TC 194 meeting in Paris from October 21-25. This important event focuses on developing biocompatibility standards for medical devices. Our experts' involvement ensures that we stay at the forefront of industry standards, directly benefiting our clients by providing them with the most up-to-date and compliant solutions. Our team is eager to contribute and collaborate with global experts to advance these critical standards. On-site team: Michelle Kelly, Marie-Eve Cluzel-Valentin, Sylvie Framery, Valériane Levelut, Austin Zdawczyk, Melissa Cadaret, Joe Carraway, Peggie Baronnier, and Loranne Mauge. Get to know our experts or request a complimentary consultation: https://lnkd.in/gW-M5upw #NAMSAKnows #ISOTC194 #Biocompatibility #MedicalDevices #Innovation

🚀 Big News! NAMSA and Terumo have teamed up in a strategic outsourcing partnership to speed up the regulatory approval and commercialization of Terumo's medical devices worldwide. 🌍 With NAMSA's expertise in clinical research, testing, and consulting, Terumo will gain immediate access to top-notch clinical experts and resources. This collaboration aims to bring life-enhancing medical solutions to market faster, benefiting patients globally. Stay tuned for more updates on how this partnership is set to revolutionize the medtech landscape! Read the full press release: https://lnkd.in/gNc8f-th #NAMSA #Terumo #MedTechInnovation #StrategicPartnership

📢 Join us for an insightful NAMSA session on effectively managing multi-region regulatory submissions for SaMD! 📢 🗣️ NAMSA Expert: Richard A. Vincins - Principal Strategy Consultant, Regulatory at NAMSA Discover how companies can leverage their existing regulatory approvals from mature markets like the United States, the European Union, or the United Kingdom to streamline multi-country registrations for software-only products. Don't miss out on this opportunity to enhance your regulatory strategy for SaMD! https://lnkd.in/gFhBG_Cm #RegulatoryAffairs #SaMD #MedicalDevices #NAMSAKnows #HealthcareInnovation

📢 Upcoming Webinar: AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy 📢 📅 Date: November 12, 2024 🕙 Time: 10:00 AM - 11:00 AM CT 🌐 Register Now: https://lnkd.in/gWNckYpe This webinar explores cybersecurity, human factors, and privacy for AI/ML SaMDs, also known as Machine Learning Enabled Medical Devices (MLEMDs), which use technologies like wireless connectivity, software as a service, and mobile platforms. Key Learning Points: ◾️ FDA's views on privacy, cybersecurity, and wireless coexistence ◾️ The CFR, GDPR, and HIPAA ◾️ Designing your product before clinical trials ◾️ Meeting FDA's human factors/usability testing requirements for AI/ML SaMDs Join us to stay ahead in the rapidly evolving digital health landscape! #MedicalDevices #HealthcareInnovation #NAMSAKnows #SaMD #AI #MLEMD

🌟 Calling all MedTech professionals! 🌟 Join us in Seoul, South Korea, for NAMSA's Biological Safety Training Course from December 2-4, 2024. This is a fantastic opportunity to enhance your skills and gain hands-on experiential learning. Participants can expect to learn how to use standards to establish a biological safety evaluation plan, as well as how to document and implement their plan. Register by October 20th to enjoy an early registration discount of up to $500 off! Don't miss out on this chance to invest in your professional growth. Secure your spot today and be part of this transformative experience! https://lnkd.in/gNfE4h-D #MedTech #BiologicalSafety #NAMSA #ProfessionalDevelopment #EarlyBirdDiscount

🔬 Breaking News for In Vitro Diagnostic Manufacturers! 📣 Attention all IVD manufacturers! The Medical Device Coordination Group (MDCG) has released the MDCG 2024-11 Guidance on the qualification of in vitro diagnostic medical devices. This comprehensive document provides crucial insights to help you navigate the regulatory landscape effectively. See the Key Highlights of this guidance outlined by NAMSA's experts below! 💡 At NAMSA, we understand these challenges and are poised to be your partner in turning them into opportunities for growth and innovation. Our clinical and regulatory experts will guide you through the new challenges, ensuring precision and alignment with the IVDR. https://lnkd.in/gWf-ZN9d

🔔 Attention Medical Device Manufacturers! 🔔 The European regulatory landscape continues to evolve, and staying informed is crucial for your success. The Medical Device Coordination Group (MDCG) has just released its latest guidance document, MDCG 2024-12: Corrective and Preventive Action (CAPA) Plan Assessment. This document provides essential guidance and templates for conformity assessment bodies (CABs), Notified Bodies (NBs), Designating Authorities (DAs), and joint assessment teams (JATs). This guidance is a valuable insight for all stakeholders involved in the conformity assessment of medical devices to ensure compliance and improve the overall quality and safety of medical devices. 💡 Need Guidance? If you’re a medical device manufacturer looking to understand the specific impacts on your company, our expert team is here to help. Reach out today for a personalized consultation and navigate the regulatory landscape with confidence! https://lnkd.in/eT4jM3w #MedicalDevices #RegulatoryCompliance #CAPA #MDCG2024_12 #QualityAssurance

Join us at MD&M Minneapolis on October 16-17! https://lnkd.in/gmw-SxUF Visit NAMSA at booth #3111 to meet our team and get connected with the best experts to help you on your product development journey. Whether you're looking for guidance on regulatory compliance or insights into the latest testing technologies, we're here to help. Don't miss this chance to connect and learn how we can support your projects. See you there! #MDMMinneapolis #NAMSA #MedicalDevices

📢 Last Chance! Join Our Upcoming Webinar: Understanding the New FDA Draft Guidance for Chemical Characterization 📢 🗓️ Date: October 9, 2024 🕙 Time: 10:00 AM - 11:00 AM CT The FDA's highly anticipated new draft guidance on chemical characterization is here! This webinar is a must-attend for industry professionals looking to understand the FDA's expectations and navigate these changes effectively. Key Takeaways: 🔍 Understanding the New Requirements: Gain a comprehensive overview of the new FDA guidance and its implications for your organization. 🛠️ Best Practices for Compliance: Learn practical strategies to ensure your chemical characterization processes meet the new standards. Don't miss this opportunity to stay informed and ensure your organization is prepared for the new regulatory landscape. https://lnkd.in/g9gJNvB3 to secure your spot! #FDA #ChemicalCharacterization #NAMSA #Webinar #RegulatoryCompliance

📢 Join us for an insightful NAMSA session on designing clinical trials for Software as a Medical Device (SaMD)! 📢 In this session, we'll cover two major points: 👉 Valid Clinical Association: Ensuring the device's outputs align with clinical needs, sometimes requiring prospective data collection. 👉 Clinical Validation: Demonstrating the device's performance in its intended use population, including sensitivity, specificity, and overall impact on the user. Using examples like ultrasound diagnostics, we'll explore how to show regulators and users that your SaMD meets the necessary performance standards. Don't miss out on this opportunity to enhance your understanding of SaMD clinical trials! https://lnkd.in/gFhBG_Cm #ClinicalTrials #SaMD #MedicalDevices #NAMSAKnows