NAMSA

🚀 NAMSA Blog Alert! 🚀 Discover cost-effective strategies for Post-Market Clinical Follow-up (PMCF) under the MDR in our latest blog: "Real-World PMCF Under the MDR: Cost Effective PMCF Strategies and Plans." 🔍 Key Highlights: ◽️ Understanding the continuous PMCF process under the MDR. ◽️ Exploring diverse methods for collecting clinical data. ◽️ Developing effective PMCF plans that align with regulatory requirements. ◽️ Ensuring ongoing compliance and enhancing patient safety. 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 here: https://lnkd.in/gQ-G5Agh #MedicalDevices #MDR #PMCF #ClinicalData #PatientSafety #NAMSAKnows

🔍 STEP 1: Defining Your PMCF Strategy with Precision Embarking on the journey to meet MDR requirements begins with a well-defined PMCF strategy. At NAMSA, we believe in laying a strong foundation before leaping into action. Why is this initial step crucial? Because satisfying your Notified Body and adhering to MDR mandates is contingent upon collecting pertinent data effectively and efficiently. Here's how we approach it: 🤝 Collaborative Evaluation: Working alongside our clients, we assess various elements such as costs, practicality, timelines, and the volume of marketed devices 🧠 Scientific & Business Insight: Integrating scientific rationale with strategic business decisions to shape your PMCF strategy 📈 Expert Input: Leveraging insights from our clinical and regulatory teams to craft a comprehensive strategy ✅ Strategic Alignment: Ensuring the strategy resonates with your objectives and our combined expertise Don't navigate the complexities of PMCF alone! 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

🎉 NAMSA News! 🎉 NAMSA is thrilled to celebrate Endotronix's FDA Premarket Approval of the Cordella PA Sensor System! 🏆 The Cordella platform is a game-changer—it's the first and only PA pressure-guided system that lets patients manage their health from home using daily PA pressure and vital signs. This means better therapeutic management and improved patient outcomes. 🌟 We're incredibly proud to have supported Endotronix on this journey. "It is an exciting time at Endotronix, and we are grateful for NAMSA's deep expertise and guidance that helped us design and execute a successful clinical trial and ultimately obtain PMA approval." As the world's leading Medtech CRO, NAMSA is dedicated to moving your medical device through the development lifecycle as efficiently and cost-effectively as possible. Want to know more about the Cordella PA Sensor System? Check it out: https://lnkd.in/g_wp6Z9H #MedTech #HealthcareInnovation #NAMSAKnows #FDAApproval #PatientCare

📢 Upcoming Webinar: Navigating the FDA Phase Out Policy for Laboratory Developed Tests (LDTs) 📢 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

📢 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

🎙️ New on BiocompCHATibility Podcast! Dr. Phil Smiraldo returns to discuss the tricky topic of equivalency in biocompatibility. He explores why a similar device doesn't always mean an equivalent one and the importance of detailed assessments. Key takeaways: -Ensuring identical materials and proper device categorization -The depth of detail needed for proving equivalence -Adherence to standards is crucial Tune in for valuable insights that could impact your approach to medical device evaluation! 🔗 Listen now! https://lnkd.in/gx6YC_DV #BiocompCHATibility #MedicalDevices #Podcast #NAMSAPodcast

🔍 Are you up to speed with PMCF obligations under the EU MDR for your medical devices? NAMSA's Expertise in PMCF Can Guide You Through: 📊 Strategizing Data Collection: What data to collect, and the best ways to gather it 🗺️ Detailed Planning: Developing a plan that ensures efficient execution of the strategy 📌 Efficient Data Collection: Implementing systematic methods for data acquisition, while ensuring accuracy and relevance of the information collected 📝 Robust Reporting: Preparing a PMCF report tailored to meet Notified Body expectations Don't navigate the complexities of PMCF alone! 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

📣Discover the pinnacle of Microbiology Testing Services with NAMSA. Our unmatched expertise in the medtech industry ensures accurate testing and streamlined timelines, guaranteeing certainty in your results. Trust NAMSA for all your critical microbiology needs. 👉Elevate your products with our exceptional services. Visit our webpage now for more information https://lnkd.in/ehmrZNj, backed by 54 years of experience at NAMSA. #NAMSA #MicrobiologyServices #NAMSA_Knows

🚀 Stay Ahead with NAMSA! New MDCG Guidance Unveiled on MDR Vigilance 📋 Key Highlights: -Template Power: Check out the DSVG Template (MDCG 2024-1) for standardized vigilance reporting -Device-Focused Expertise: Examine DSVGs for cardiac and breast implants, among others -Future Readiness: Expect more device-specific guidances to come 🔍 Understanding the Essence: Learn how these guides help with vigilance reporting, clarifying incidents, PSRs, and trends 🔗 Harmonizing Compliance: MDCG 2024-1 seeks to ensure compliance with MDR and IVDR 🌐 NAMSA offers regulatory guidance and support for trending processes and post-market surveillance. 💡 Ready to Elevate Your Vigilance Strategy? Dive into our blog for more details. Read the full blog here: https://lnkd.in/e8WquuEG #MDR #VigilanceGuidance #MedicalDevices #NAMSAKnows

Check out episode 36 of NAMSA's BiocompCHATibility podcast, where the hosts are joined by Dr. Charles Ducker who recently returned from Korea on a trip to give training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Discussion centers around the use and adoption of ISO 10993-18 by Korean authorities, as well as challenges for device manufacturers and testing labs. The episode covers key topics like Korea's stance on ISO 10993-18, laboratory qualification for chemical characterization testing and discussions on solvents and temperatures. Tune in for this enlightening conversation! https://lnkd.in/dc6QaK7K #podcast #chemistry #MFDS #ISOstandards