NAMSA

🚀 NAMSA Blog! 🚀 Discover the key areas of payer research in our latest blog: Medical Device Reimbursement Payer Research: Key Areas of Payer Research 📊🔍 https://lnkd.in/g72_4JxK 🔹 Benefits of Payer Research: Understand the decision-making processes of healthcare payers, from insurance companies to government programs like Medicare and Medicaid. Gain insights to align your strategies with payer preferences and secure favorable assessments for your medical devices. 🔹 Methods for Payer Research: Explore various methodologies such as surveys, interviews, data analysis, and literature reviews to gather comprehensive insights into payer behavior and decision-making. 🔹 Market Access & Reimbursement: Learn how thorough payer research can help you gather robust clinical and economic evidence, shape clinical trials, and develop effective pricing strategies to ensure broad patient accessibility and favorable coverage decisions. Stay ahead in the healthcare industry by leveraging payer research to enhance your market access strategies and ensure the success of your innovative medical devices. 🌟 #MedicalDevices #Healthcare #PayerResearch #Reimbursement #NAMSA #MarketAccess

NAMSA is delighted to celebrate Cordis who have secured FDA PMA approval of its MYNX CONTROL™ VENOUS Vascular Closure Device (VCD)! 🎉 This groundbreaking device integrates active extravascular sealing and resorb-ability properties with a next-generation delivery system to maximize predictability, safety, and ease of use in sealing 6-12F femoral venous access sites. The MYNX CONTROL™ VENOUS VCD leverages GRIP TECHNOLOGY™, based on hydrophilic, bioinert polyethylene glycol (PEG), providing significant reduction in Time to Hemostasis and excellent safety profile. The sealant resorbs 3x faster than collagen-based sealants, offering a significant improvement in patient care. 💉🩹 We are incredibly proud to have supported Cordis on this journey. NAMSA's dedicated Clinical, Safety, Biostatistics, Core lab, Global Strategy Services and Medical Writing team members worked closely with Cordis on its FDA PMA Approval. 🤝 Read more about this exciting development on Cordis's website: https://lnkd.in/eQCtYAfh #MedicalDevices #FDAApproval #HealthcareInnovation #PatientCare #NAMSAKnows

🎙️ Are you navigating the complex waters of biocompatibility in early feasibility studies? Tune into our latest BiocompCHATibility Podcast episode for expert insights! Our hosts dive into the essentials of controlling device response in initial patient trials and how this shapes the entire biocompatibility process within risk management frameworks. Key takeaways include: ✔ Crafting a biological safety plan that grows with your project ✔ Establishing a solid evaluation strategy from the start ✔ Designing studies for high-risk cardiovascular implants with a focus on safety Don't miss out on these valuable discussions. Listen now to stay ahead in the world of medical device development! https://lnkd.in/g6y6G8nb #Biocompatibility #MedicalDevices #RiskManagement #SafetyPlanning #NAMSAPodcast

📢 MedTech Matters Episode 6 - Key Considerations for Chemical Characterization Programs 🧪 This video in the MedTech Matters series features Charles Ducker, Senior Director of Analytical Services for North America at NAMSA. Charles discusses the challenges faced by chemistry teams and the insights they provide to sponsors for device safety and regulatory compliance. Watch the video here: https://lnkd.in/gt8PAXy2 In this episode, Charles highlights key aspects of chemical characterization testing and its role in understanding device biocompatibility. At NAMSA, we understand that chemical characterization testing is just one part of the services sponsors need. Our team excels in biocompatibility, toxicological risk assessment, biological safety plans, and more – all under one roof.

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