NAMSA

Explore your market's potential with NAMSA's Market Research! 🌐💡 Seeking insights from physicians for your product or looking to better understand client preferences? NAMSA offers extensive market research, with over 100,000 participants and decades of experience, conducting 30,000+ interviews yearly in all MedTech areas. Why Choose NAMSA? 🚀 Extensive Reach: Our 100,000+ participant database ensures diverse and comprehensive insights 💼 Expertise Matters: With decades of experience, we design studies that truly uncover the pulse of your market 🌍 Global Impact: Operating across all MedTech therapeutic areas, we provide insights with a global perspective Ready to Navigate Your Market Landscape? Learn more today! 📊👥 https://lnkd.in/dfPhAqqg #MarketResearch #MarketInsights #MedTech #NAMSA #SUAZIO #NAMSAKnows

📢 Join us for the Biological Safety Training in Lyon! 🌟 Date: September 16-19, 2024 Location: Hôtel Sofitel Lyon Bellecour, Lyon, France Course A: Biocompatibility of Medical Devices – Two-Day Certification Course 📅 Date: September 16-17, 2024 Course B: Toxicological Risk Assessment – Two-Day Certification Course 📅 Date: September 18-19, 2024 The release of ISO 10993-1:2018, 10993-18:2020, and the MDR GSPR brings new challenges for medical device manufacturers. This course is designed to tackle these challenges and provide hands-on learning. Perfect for those needing a working knowledge of biocompatibility or looking to update their skills. Register for both Course A & Course B - Early Registration Discount until August 4, 2024! 👉 Visit https://lnkd.in/gTgvpt69 for more details and registration. #NAMSAKnows #BiologicalSafety

🚀 NAMSA Blog 🚀 Curious about the best practices for developing a Summary of Safety and Clinical Performance (SSCP)? Read the full article: https://lnkd.in/ggdaW-PY 🔍 Key Highlights: ✔️Follow the Latest MDCG Guidelines: Learn how to align your SSCP with the latest MDCG and TEAM-NB guidelines to ensure compliance and avoid non-conformities. ✔️Harmonization Among Documents: Ensure consistency across Clinical Evaluation Reports (CER), Instructions for Use (IFUs), and other technical documentation. ✔️Appropriate Content: Focus on safety and performance data, avoiding promotional content. ✔️Audience Consideration: Make the SSCP accessible to both healthcare professionals and patients, with appropriate readability and length. ✔️Readability Tests: Conduct readability tests to ensure the SSCP is understandable for its intended audience. Our Consulting team is ready to assist you in developing compliant and effective SSCPs. #MedicalDevices #MDR #SSCP #ClinicalData #PatientSafety #NAMSAKnows

Don't miss NAMSA at ADLM 2024! Our team is eager to meet you all and discuss your IVD service needs. 📍 Find us at Booth #2355 🆓 Free consultations on-site 👂 Hear from our on-site SMEs on several trending topics in the IVD industry - IVDR Transition Strategies (Warren Jameson, Ph.D) - LDT to IVD Conversion (Warren) -Site Partnerships to Accelerate IVD Clinical Trials (Cindy Wuertz RN, BSN, MBA) Join us for a chance to network and explore collaborative opportunities. See you there! https://lnkd.in/gP3Zu4yX #ADLM #AACC #Innovation #Networking

📢 Upcoming Webinar: Navigating the FDA Phase Out Policy for Laboratory Developed Tests (LDTs) 📢 🗓️ Date: August 22, 2024 🕙 Time: 10:00 AM - 11:00 AM CT 🔗 https://lnkd.in/eixcb-Eu Join us for an insightful webinar that will provide an in-depth overview of the FDA's phase-out policy and its impact on laboratories. This webinar is designed to help laboratories understand and navigate the various stages of the phase-out policy, the associated risks, and the steps needed to ensure compliance. What You'll Learn: ◾️Overview of Phases: Walkthrough of phase-out policy stages starting May 6, 2025, and FDA expectations including MDR and QMSR compliance. ◾️Business Landscape Update: Insights on the NY enforcement discretion clause. ◾️Current Phase Execution: Guidance on quality requirements, Medical Device Reporting, CLIA vs. QMSR assessment, and reporting changes. ◾️Risks and Delays: Potential implementation risks and delays, including ruling stops. Speakers: Warren Jameson, Ph.D Senior Manager, Regulatory & Quality Erika Lokander Regulatory Affairs and Quality Assurance Specialist 👉🏻This webinar is a must-attend for all laboratories impacted by the FDA phase-out policy. It will provide you with the knowledge and tools needed to navigate this complex policy and ensure your laboratory remains compliant. Register today to secure your spot. We look forward to seeing you there! #FDA #LDT #Webinar #MedicalDevices #RegulatoryCompliance #NAMSAKnows

🚨 Breaking News! 🚨 NAMSA is thrilled to celebrate securing FDA De Novo clearance for their pioneering BioHealx™ technology! BioHealx™ is an innovative medical device designed to treat anal fistula, a painful and debilitating colorectal condition. Developed with expert colorectal surgeons 👨⚕️👩⚕️, BioHealx™ is a single-use, bioabsorbable implant used in a minimally invasive procedure. This novel treatment promotes healing 🩹, prevents recurrence, and protects patient continence, potentially transforming the lives of patients suffering from this condition. Read more: https://lnkd.in/d_WcuvP We are incredibly proud to have supported Signum Surgical on this journey. NAMSA's dedicated GSS (Global Strategy Services) and medical writing team worked closely with the client on their FDA De Novo submission. 📝🤝 Congratulations to Signum Surgical on this exciting achievement! #MedicalDevice #Innovation #Healthcare #RegulatoryAffairs #BioHealx #NAMSA #FDAClearance #PatientCare

✒️ STEP 4: Crafting the PMCF Evaluation Report with Expertise and Insight The culmination of diligent PMCF activities is the creation of a comprehensive PMCF Evaluation Report. This document is pivotal, as it encapsulates all the data collected and provides an analysis that informs future actions and regulatory compliance. MDCG 2020-8 offers a foundational structure for what the report should encompass. However, the true value lies in understanding and meeting the nuanced expectations of Notified Bodies. NAMSA's extensive experience across a broad spectrum of PMCF projects and device types has honed our ability to discern precisely what is required. Our expertise enables us to: 📝 Draft Detailed Reports: We articulate findings clearly and concisely, ensuring they align with regulatory standards 🔍 Analyze Data Thoroughly: Our analysis goes beyond surface-level insights, delving into the implications and significance of the data 🔄 Update Key Documents: The insights gained will be used to refresh your Clinical Evaluation Report (CER), Risk Management File, Summary of Safety and Clinical Performance (SSCP), among others By entrusting NAMSA with your PMCF Evaluation Report, you ensure that every step of your PMCF process is not only compliant but also contributes to the overarching goal of patient safety and product efficacy. Discover how NAMSA can support your compliance journey and enhance your market success. https://lnkd.in/ghEtDuvZ #PMCF #PMCFStrategy #PMCFPlan #PMCFReport #PMCFStudy #MedicalDevices #MDR #NAMSAKnows #CRO

🚀 News from NAMSA! 🚀 We are thrilled to announce that NAMSA is now offering the Beta-Thromboglobulin (β-TG) Assay, a cutting-edge in-vitro hemocompatibility test designed to determine platelet activation of blood-contacting test articles per ISO 10993 Part 4. 🔬 Key Highlights: ◽️Innovative Testing: The β-TG Assay measures platelet activation through the release of β-TG protein using a commercially available ELISA kit. ◽️Accurate Results: Utilizing freshly collected human blood, the assay ensures precise measurement of β-TG concentration, directly proportional to the risk of platelet activation. ◽️Comprehensive Analysis: The assay follows the same exposure principles as the ASTM-F2888 Platelet Leukocyte Count Assay and the Thrombin Anti-Thrombin Assay, allowing for comprehensive hemocompatibility testing. Our Minneapolis lab has recently validated this assay, making it an essential addition to your biocompatibility testing program. 🌟 🌐 To learn more about NAMSA's test offerings visit: https://lnkd.in/ehmrZNj #NAMSAKnows #BiocompatibilityTesting #MedicalDevices #Hemocompatibility #InnovationInTesting #Healthcare

Join us at the upcoming Joint Statistics Meeting on August 6, 2024, where our very own Tyson Rogers from NAMSA will be showcasing his expertise. Don't miss out on his poster presentation titled "Effective Use of Simulation and Resampling Methods for Medical Device Studies." 📊 Dive into the world of advanced statistics with Tyson as he unravels the complexities of simulation and resampling methods, demonstrating their crucial role in medical device research. 🕥 Set your reminders for 10:30 AM - 12:20 PM to catch this insightful session. It's a golden opportunity to learn from one of the best and enhance your understanding of statistical applications in the medical field. See you there! #JSM2024 #Statistics #MedicalDevices #ResamplingMethods #NAMSA

🚀 NAMSA Blog 🚀 Discover the significance of Post-Market Clinical Follow-Up (PMCF) surveys in our latest blog: When, Why, and How to Use Post-Market Clinical Follow-Up (PMCF) Surveys. 🔍 Key Highlights: ◾️Real-World Evidence: Understand how PMCF surveys provide essential data on device safety and performance ◾️Regulatory Compliance: Learn how these surveys help meet EU MDR requirements ◾️Cost-Effectiveness & Time Efficiency: Explore the benefits of high-quality surveys that save time and budget ◾️Global Reach & Versatility: Discover how online surveys can gather diverse data from a global population At NAMSA, we leverage our extensive regulatory and clinical expertise to support manufacturers at every step, ensuring all aspects of PMCF are thoroughly addressed. 📖 Read the full blog to learn more! https://lnkd.in/gJKncEBE #MedicalDevices #MDR #PMCF #ClinicalData #PatientSafety #NAMSAKnows