NAMSA

Clinical trials ensure new products are safe and effective. At NAMSA, we understand their complexities. Our blog post, "Components of Effective Clinical Trial Management," explores key elements for successful trials. 🔍 Key Highlights: ◾️ Regulatory Compliance: Navigate the maze of regulations with ease, ensuring ethical and reliable trials. ◾️ Cross-functional collaboration: Foster seamless teamwork across clinical operations, regulatory affairs, and more. ◾️ Organizational Structure: Implement tools like checklists and trackers to maintain accountability and transparency. ◾️ Leveraging Technology: Utilize EDC and eTMF systems for efficient data management. ◾️ Timelines & Financial Oversight: Keep your trials on schedule and within budget. ◾️ Vendor Management: Build strong relationships with vendors for quality deliverables. ◾️ Safety Committees: Ensure participant safety with CEC and DSMB oversight. 💡 Expert Insights: Dr. Raquel Sofia Cordeiro, with her extensive experience in clinical research, shares practical tips to enhance your trial management strategies. 🔗 Read the full article here https://lnkd.in/gaiPhRdx and discover how NAMSA's expertise can guide you towards successful clinical trials. #ClinicalTrials #ProjectManagement #MedicalResearch #NAMSAKnows

Explore the world of post-market clinical follow-up (PMCF) with industry leaders as they unravel the complexities of regulatory aspects, surveys, and clinical studies. Discover best practices that will help manufacturers meet the requirements of the MDR and Notified Body expectations. 🔍 Key Learning Objectives: ◾️ Understand the context of PMCF within the EU MDR ◾️ Differentiate between surveys and studies ◾️ Identify the appropriate PMCF strategy based on device type and market duration ◾️ Best practices for developing surveys and PMCF studies 🎤 Meet Our Speakers: Sara Finocchietti, MENG, PHD Senior Strategy Consultant, Clinical ◾️ With 15 years in the medical device industry, Sara specializes in orthopedics, neurovascular, and neuroscience. Jasper van de Sande Senior Business Consultant, SUAZIO (Now Part of NAMSA) ◾️ Jasper brings 20 years of experience, focusing on market insights and PMCF studies. Adrian Keene, BSC (HONS) Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services ◾️ Adrian offers over 30 years of expertise in product development and registration. Paul Risborough, B-Eng (HONS) Principal Regulatory Consultant ◾️ With over 25 years in the industry, Paul has developed numerous MDR-compliant PMCF plans and reports. Don't miss this opportunity to gain insights from the best in the field. Register now and secure your spot! 🔗 Register Here: https://lnkd.in/gy4GdrKT #NAMSAKnows #Webinar #PMCF #MedicalDevices #RegulatoryAffairs #MDR #NotifiedBody #ClinicalStudies

Join us for NAMSA's upcoming webinar where we'll explore how proposed FDA cuts could affect your clinical research projects. Engage with experts like Doctors Leon, Granada, and Ouriel, alongside Dr. Jeff Shuren, former Director of CDRH at the FDA. They'll dive into current challenges in the MedTech industry and discuss how changes at the FDA might impact innovation timelines and product development. Key Topics: ◾️ Innovation costs and timeliness ◾️ Preclinical testing and clinical trial designs ◾️ FDA workflow changes and product approval ◾️ New interaction strategies with the FDA Don't miss this chance to gain insights and strategies to navigate these changes. Register now! https://lnkd.in/gcRwp45F #MedTech #FDAChanges #ClinicalResearch #Innovation #Webinar

Attending BTEL 2025 in Berlin on March 26-27? Don't miss NAMSA's expert, Dr. Kimberly Ehman, who will be speaking on "Incorporating Emerging Toxicological Challenges into Toxicological Risk Assessment for Medical Devices." Dive deep into the world of endocrine disruptors and explore ISO 10993 Parts 3 and 17. See you there! #BTEL2025 #NAMSA #MedicalDevices #Toxicology

🌟 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

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. #NAMSA #MedicalDevices #Cytotoxicity

🎤 NAMSA Speakers at ACRP 2025! 🌟 Join us as our experts take the stage to share their insights: -Wendy Schroeder will delve into "Comparing and Contrasting Approaches to In Vitro Diagnostics Research vs. Other Medical Devices." Discover the nuances and strategies in this evolving field. -Patti Smith will explore "Is Your Electronic Data Capture Fit for Purpose?" Gain valuable tips to optimize your data management processes. Don't miss these sessions for a deep dive into the latest trends and innovations. See you there! Check out other upcoming events NAMSA will be at: https://lnkd.in/g7TVibWH #NAMSA #ACRP2025 #MedicalDevices #InVitroDiagnostics #DataCapture

🚀 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