NAMSA

🚀 New Insights from NAMSA! 🚀 Check out our recent blog post, "Key Components of a Biological Evaluation Plan (BEP)," to learn how a well-structured BEP ensures the safety of medical devices. A BEP is essential for assessing biological risks, covering everything from regulatory guidance to device composition and manufacturing processes. It identifies potential hazards and outlines risk control measures to ensure patient safety. Stay informed in the medical device industry by understanding the importance of a comprehensive BEP. Read more here: https://lnkd.in/gJAN9_MH #MedicalDevices #BiologicalEvaluation #NAMSA #PatientSafety #RiskManagement

🚀 Dive into the latest insights from NAMSA's blog on the new FDA draft guidance for medical device chemical characterization! This comprehensive framework aligns with ISO 10993 Part 18, focusing on extraction, chemical analysis, and reporting requirements to boost the safety and effectiveness of medical devices. Key highlights include: -The critical role of thorough information gathering -Tailored extraction procedures for different device types -Emphasis on NVR analysis for prolonged use devices -Multi-method approaches to chemical analysis Stay informed and ensure your devices meet the highest standards. Check out the full blog post here: https://lnkd.in/gEfBsP7n #MedicalDevices #FDAGuidance #ChemicalCharacterization #NAMSA #ISO10993

Join us for NAMSA's upcoming webinar, "Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes?" Dive into the world of biocompatibility testing and discover if cytotoxicity assays can truly predict in vivo outcomes like acute systemic toxicity, intracutaneous irritation, and sensitization. Key Takeaways: -Understanding Cytotoxicity Assays: Explore their traditional role and predictive value. -Data-Driven Insights: Discover findings from extensive data analysis on thousands of studies. -Future Directions: Discuss implications for regulatory practices and research. Don't miss out on this chance to learn from experts and enhance your knowledge. Register now: https://lnkd.in/gws_WV4N #NAMSA #MedicalDevices #Cytotoxicity

Join us at SOT 2025 in Orlando, FL, from March 16-20! Don't miss the posters from Cayla Ruch, PhD, DABT "Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes?", which has been awarded 2nd place in the Medical Device and Combination Product Specialty Section (MDCPSS) Best Overall Abstract, as well as a poster from NAMSA's Courtney Jamison and Kimberly Ehman PhD, DABT "Biological Evaluation Gaps for Tampon Products-What Have We Missed and How Do We Move Forward?". Visit NAMSA at booth #1116 to discuss your medical device or product and connect with our experts. Don't miss out on the chance to learn how we can support your success. See you there! https://lnkd.in/gujpkp9C #SOT2025 #NAMSA #Innovation

Join us at LSI USA from March 17-21! Visit NAMSA's booth to connect with our team, including CEO Brian Smith, Ivanny Franklin, Adam Saltman, Andrew Suri, and Jeff Geschwind. Don't miss the workshop "Avoiding the Valley of Death" on March 20, 12:45pm - 1:25pm, led by Ivanny and Adam alongside other industry leaders. They'll share key strategies for startups to secure funding, navigate regulations, and build successful partnerships. See you there! https://lnkd.in/gAF_kkxW #LSIUSA #NAMSA #StartupSuccess

🌍 Navigating the Impact of PFAS Regulations on Medical Devices 🌍 The world of medical devices is facing a significant shift due to evolving PFAS regulations. Our latest blog post dives into the complexities of these changes and their potential impact on the industry. PFAS, known as "forever chemicals," are used in various medical technologies for their unique properties. However, increasing regulatory restrictions, especially in the EU and US, could lead to supply chain disruptions and a shortage of critical medical components. Medical device manufacturers must act swiftly to find alternatives to PFAS to ensure the continued availability and quality of life-saving technologies. 🔗 Read more about the impact of PFAS regulations on medical devices: https://lnkd.in/g47Dm8-G #MedicalDevices #PFAS #Regulations #NAMSA #HealthcareInnovation

🌟 Elevate Your Expertise in Medical Device Biocompatibility! 🌟 Join us for an exclusive in-person training series in San Diego, designed to enhance your skills and knowledge in the biocompatibility of medical devices. This is a unique opportunity to learn from industry experts and gain certification. 📋 Course A: Biocompatibility of Medical Devices 📅 Date: March 31-April 1, 2025 📍 Location: Alma San Diego Downtown, a Tribute Portfolio Hotel 🔍 Dive into the latest updates in ISO standards and MDR requirements. Gain hands-on experience and become a certified Biological Safety Specialist. 📋 Course B: Continuing Education for the Biological Safety Specialist 📅 Date: April 2-3, 2025 📍 Location: Alma San Diego Downtown, a Tribute Portfolio Hotel 📈 Enhance your skills with advanced workshops and real-world case studies. Learn to navigate complex regulatory expectations and toxicological assessments. 💻 Register for both courses and save! Dates: March 31-April 3, 2025 Meet Our Expert Speakers: ✔️ Don Pohl, BS, Principal Strategy Consultant, Biocompatibility ✔️Phillip Smiraldo, PhD, DABT, Principal Toxicologist Don't miss this chance to advance your career and network with peers and industry leaders. Secure your spot today! 👉 Register Now: https://lnkd.in/g48Cdqnm #BiologicalSafety #MedicalDevices #NAMSA #ISO10993 #Biocompatibility #MedicalTraining #NAMSAKnows

🔬When it comes to successful MedTech preclinical research, NAMSA understands that experience matters. With four global preclinical laboratory facilities, NAMSA assists in ensuring the most efficient, timely, and successful outcomes in your medical device development process. That is why NAMSA has amassed the largest breadth and depth of therapeutic device expertise and knowledge compared to any other preclinical development partner in the industry. Our Belgium lab highlights: ☑️State-of-the-art operating theaters, intensive care unit, imaging, and animal accommodation ☑️Unmatched expertise with Large Animal Models ☑️Unparalleled expertise in cardiovascular medical devices, as well as orthopedic, gastrointestinal, ophthalmic, neurosurgery, and urology. 📣Ready to revolutionize your products? Explore our webpage now! 👉https://lnkd.in/eDuYu7ZN or request to be contacted to contact us 🌐https://lnkd.in/eT4jM3w #PreclinicalServices #Lab #NAMSAKnows

Join us at the SOT 2025 in Orlando, FL, from March 16-20! Visit NAMSA at booth #1116 to discuss your medical device or product and connect with our experts. Don't miss out on the chance to learn how we can support your success. See you there! https://lnkd.in/gujpkp9C #SOT2025 #NAMSA #Innovation

Join us at KIMES in Seoul, South Korea to hear from NAMSA expert, Brandon Woll, MBA; Principal Strategy Consultant, on March 20, 2025. He will take the stage to discuss "Recent Trends of FDA Regulatory Requirements & Presub Meeting Strategies and Cases" from 15:00-17:00. Mark your calendars and gain valuable insights to enhance your regulatory strategies! For more details, visit: https://lnkd.in/gX3m2qrn #KIMES #NAMSA #MedicalDevices #FDA #RegulatoryStrategy