NAMSA

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

🔎 STEP 3: Implementing Data Collection Through PMCF Activities as Outlined in Your Plan The EU MDR stipulates that, with few exceptions, the collection of PMCF data should be an ongoing process. Among the various methodologies, post-market surveys stand out as a prevalent and effective means to gather valuable insights from users and patients. NAMSA's extensive experience in designing, administering, and analyzing PMCF surveys positions us as your ideal partner for this critical step. In addition, our expertise extends beyond surveys to a comprehensive array of post-market data sources: 📊 High-Quality Clinical Surveys: Tailored to capture targeted data efficiently 📄 Individual Case Reports: Analyzing specific instances for detailed understanding 👥 Usability Surveys: Gathering direct feedback from healthcare professionals and patients 📚 Published Literature Reviews: Assessing current "state of the art" or equivalent devices for comparative analysis 📈 Clinical Registry Studies: Utilizing registries to track long-term outcomes and trends 🧪 Post-Market Clinical Studies: Conducting full or partial studies when more comprehensive data is required Embark on your data collection journey with NAMSA's support to maintain compliance and uphold the highest standards of patient care. 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

🌟 Join NAMSA at the Orange County Regulatory Association Conference! 🌟 We are excited to announce that Tyson Rogers, our Principal Strategy Consultant in Biostatistics, will be speaking at the OCRA Conference on August 2nd in Huntington Beach, CA. 📅 Event Date: August 2, 2024 📍 Location: Hilton Waterfront Hotel, Huntington Beach, CA 🎤 Lecture Topic: Real-World Evidence in Regulatory Submissions Tyson will delve into the critical role of real-world evidence in regulatory submissions, providing valuable insights and practical strategies for navigating this complex landscape. 🔍 Key Learning Objectives: ◾️Understand the importance of real-world evidence in regulatory submissions. ◾️Learn effective strategies for integrating real-world evidence into your submissions. ◾️Gain insights into overcoming common challenges in the regulatory process. Don't miss this opportunity to enhance your regulatory knowledge and network with industry experts. 👉 For more information and to register, visit: https://ocra-dg.org/ #NAMSA #OCRAConference #RegulatoryAffairs #RealWorldEvidence #Biostatistics #NAMSAKnows

🎧 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