NAMSA

🚀 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

🚀 FDA's Guidance on Digital Health Technologies! 💡 Discover the latest insights from the FDA's Industry Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. 🌐 Key Takeaways: 👉 Definition of Digital Health Technologies (DHT) and their role in remote data acquisition 📊 Examples of DHT applications in clinical trials 🛠️ Design control requirements for DHTs used as medical devices 🔍 Selection criteria for choosing DHTs in clinical investigations Ready to delve into the details? Read the full guidance document here: https://lnkd.in/eekRZVVb 🌐 And did you know? NAMSA offers support for qualification proposals to CDRH's MDDT Qualification Program! #FDA #DigitalHealth #ClinicalTrials #NAMSAInsights #MedTech #NAMSAKnows

Episode 8 of NAMSA's RAQA Café Podcast joins our hosts with special guest speaker, Wendy Schroeder, a Principal Product Development Strategist for IVD and Clinical at NAMSA. Wendy shares valuable insights into clinical investigation, clinical evaluation and the advantages and risks of participating in a clinical trial. Discussions include the importance of clinical investigations in supporting regulatory submissions and how they must align with the intended user and use environment. To learn more about clinical trials, the benefits and risks involved, and the respiratory season for clinical trials, tune in now! https://lnkd.in/gKFsM8_d #clinicalinvestigations #clinicalresearch #medicaldevices #RAQACafe

🚀 NAMSA BLOG! 🚀 The FDA, Health Canada, and MHRA have jointly released the "Transparency of Machine Learning-Enabled Medical Devices: Guiding Principles." This new publication builds upon the 2021 Good Machine Learning Practice (GMLP) principles, emphasizing the importance of transparency in MLMDs. 🧠 Key Highlights: ◾️Principle 7: Focus on the performance of the human-AI team. ◾️Principle 9: Clear, essential information for users. Transparency in MLMDs ensures informed choices, manages risks, and promotes equity by revealing biases. 🔍 Explore the six transparency principles: the audience, importance, relevant info, placement, timing, and human-centered design support. 📢 Read the full blog by Monica R. Montanez, Principal Strategy Consultant, to learn more about these guiding principles and their impact on the medical device industry 👉 https://lnkd.in/gvnCtM6w #MedicalDevices #MachineLearning #Transparency #HealthcareInnovation #NAMSAKnows

🔬 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