NAMSA

🎧 New Episode Alert! 🚀 Tune in to Episode 11 of the RAQA Café Podcast for insider tips on Effective Communication with Notified Bodies. Join our experts, Paul Risborough and Matt Royle, as they share their experiences from both sides of the table. Learn how to: 🗣️ Talk clearly with Notified Bodies 💡 Handle reviewer questions like a pro ❤️ Keep a strong relationship with your reviewers 🕊️ Solve disagreements smoothly Don't miss out on their valuable insights! Listen now and step up your regulatory game! 🔗 https://lnkd.in/gxnW8_ix

📈 STEP 2: Crafting Your Medical Device PMCF Plan With a solid PMCF strategy in place, the next pivotal step is to translate that strategy into a concrete PMCF plan. This critical document delineates the specific PMCF activities tailored for your medical device, ensuring ongoing compliance and vigilance. While MDCG 2020-7 offers a template for a PMCF plan, it falls short of guiding you through the nuances of execution or aligning with Notified Body expectations. That's where our expertise comes into play: 📝 Tailored Documentation: Our clinical and regulatory teams, experienced in global PMCF requirements, will develop a comprehensive PMCF plan that details the methodologies for data collection 🔍 Safety and Performance Confirmation: We'll outline procedures to continuously verify your device's safety and performance 🚨 Risk Management: Identifying potential unknown side effects, emergent risks, and instances of off-label use or systematic misuse ⚖️ Benefit-Risk Assessment: Ensuring the benefit-risk ratio remains favorable as per your risk management framework Let us guide you in developing a PMCF plan that not only meets regulatory standards but also supports the continued success of your medical device on the market. 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

Having the right medical device regulatory consulting partner at the right time can be invaluable in attaining compliance and market access. NAMSA is the industry leader in driving successful medical device and IVD regulatory submissions/outcomes through: -Effective, daily interactions with the U.S. FDA, Japan's PMDA, Europe's Notified Bodies, China's NMPA and other international authorities -On-demand external support and expertise-many of our Associates have previously held positions with regulatory bodies, which provides you the benefit of a clear understanding on how to proactively plan for international requirements and expectations -Developing and implementing global regulatory strategies to accelerate your specific commercialization efforts Whether the goal is to extend your in-house capabilities or obtain access to the specialized expertise you need, our medical device regulatory consulting team can support. Learn more by visiting https://lnkd.in/gxF4zjvn #regulatoryconsulting #medicaldevices #NAMSAKnows

🎙️New MedTech Matters Episode: The Value of Market Insights 🌐💡 In this episode, Christophe Van der Linden (Executive Director of Market Research & Insights) shares invaluable insights on why market research is a game-changer for bringing innovative medical devices to market. 🔍 Key Highlights: - Importance of market insights in MedTech - Real-world impact of effective market research - NAMSA's role in shaping successful market strategies NAMSA is your go-to partner for MedTech market research, boasting 1500+ projects, 100,000+ participants and fluency in 35+ languages to propel your ideas. 🌟 Ready to gain a competitive edge? Watch the episode now: https://lnkd.in/g8MDMcKv #MedTechMatters #MarketResearch #MedTech #NAMSAKnows

🔬RAPS Webinar: Navigating Early Feasibility and First-in-Human Studies: A Comparative Analysis of EU and US Approaches 📅 Date: July 16th, 2024 ⏰ Time: 10-11:00 am Eastern Time 🔍 Overview: Join us for a RAPS webinar featuring NAMSA experts as they provide a comparative analysis of Early Feasibility and First-in-Human Studies in the EU and US. Gain insights into regulatory landscapes, clinical trial processes, and the key differences between these two major markets. 📚 What You'll Learn: ◾️ The US Approach to Early Feasibility Studies ◾️ Navigating EU Regulations for First-in-Human Studies ◾️ Comparative Analysis of US and EU regulatory and clinical trial processes 🎤 Expert Speakers: ▪️ Dr. Pedro Eerdmans, Clinical Director, Global Strategy Services ▪️ Richard A. Vincins, Principal Strategy Consultant ▪️ Carla M.Wiese, Principal Strategy Consultant ▪️ Nimrita Verma, Clinical Study Manager Whether you're a seasoned professional or new to the field, this webinar will enhance your understanding and help you make informed decisions in these complex regions. 🔗 Join Us: https://lnkd.in/gZNiMyAF #RAPS #NAMSAKnows #NAMSA #ClinicalTrials #MedicalDevices #RegulatoryAffairs

🚀 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