NAMSA

📢 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

🔬 Webinar Alert: Wound Care Laboratory Testing Requirements: Your Path to Compliance 🚀 Are you ready to navigate the complexities of wound care compliance? Join us on July 11th for an in-depth webinar that will arm you with the knowledge to stay ahead in the dynamic field of wound care. 🩹 What You'll Learn: ◾️ The critical role of in vitro testing and the impact of the updated EN13726 standard ◾️ FDA and EU regulatory requirements specific to wound care, with insights from regional auditors ◾️ Strategies for employing the right test methods to accelerate product development and achieve regulatory approval efficiently 📅 Mark your calendar: Date: July 11, 2024 Hour: 10:00 AM US Central Time Don't miss this opportunity to enhance your understanding and ensure your wound healing devices are compliant and effective. ✅ Register now and take the first step towards compliance mastery! https://lnkd.in/gKR49Xwq #WoundCare #LaboratoryTesting #RegulatoryCompliance #MedicalDevices #NAMSAKnows

🚀 NAMSA Blog! 🚀 We're excited to announce the release of our latest blog: MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices by Paul Risborough, our Principal Regulatory Consultant. 🔍 Key Highlights: ✔️Understanding Orphan Devices: Learn what qualifies a device as an orphan device under the new MDCG 2024-10 guidance. ✔️Challenges and Solutions: Discover the difficulties in generating clinical data for rare diseases and how the new framework addresses these challenges. ✔️Regulatory Compliance: Get insights on how to justify orphan device status and navigate the increased requirements of the Medical Device Regulation (MDR). Essential for manufacturers, this guidance helps deliver care to small patient populations. 🌟 For orphan device status and clinical strategy support, contact our expert team today! 💡 📖 Read the full blog here: https://lnkd.in/gSFMfVbE #MedicalDevices #OrphanDevices #MDR #ClinicalEvaluation #HealthcareInnovation #NAMSAKnows

🌟 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 Orange County Regulatory Affairs Discussion Group 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

Check out this insightful article by NAMSA expert Sara Finocchietti titled "Randomized controlled trials are not always the solution". The piece offers a fresh perspective on the pre-market clinical evaluation of implantable medical devices, particularly in the cardiovascular domain. It highlights that while randomized controlled trials (RCTs) are crucial, they may not always be feasible or ethical, especially for vulnerable populations. This article is a must-read for anyone interested in the evolving landscape of medical device evaluations. Join the discussion! https://lnkd.in/dnEEfknq #MedicalDevices #ClinicalResearch #NAMSAKnows