NAMSA’s Post

When it comes to clinical trials, quality compliance is key to success. It lays the foundation for quality assurance and helps maintain it throughout the entire process, all the way until FDA approval. If you're involved in clinical trials, make sure to prioritize clinical quality compliance from the very start to ensure a successful outcome. #ClinicalTrials #QualityCompliance #FDAApproval #Success

CE Mark Consulting: NAMSA's Comprehensive Solutions🔎 Obtaining a CE Mark for your medical device can be complex and involves several regulatory hurdles to navigate. Whether you are embarking on your first device to be CE marked or taking your device portfolio through the transition to the MDR, with a global team of regulatory consultants, made up of former Notified Body staff and experts, NAMSA offers extensive consulting services to guide you on this intricate path. ✔️Regulatory/clinical strategy including classification: Find the most expedient pathway to CE marking under the MDR. ✔️Development and compilation of technical documentation, including: ◾️ISO 14791 risk management. ◾️Clinical Evaluation Plan and Report (CEP/CER) ◾️Post Market Clinical Follow-Up (PMCF) strategy and implementation ◾️Summary of Safety and Clinical Performance (SSCP) ✔️Development and implementation of Quality Management Systems (QMS) to meet MDR and ISO13485:2016 requirements. ✔️Full biocompatibility services under ISO 10993. ✔️Selection of Notified Body (NB) and ongoing engagement: our ex-NB experts have the experience that can make a difference. ◾️Leading/support in calls/meetings with notified bodies ◾️Non-conformity analysis, advice, resolutions ✔️Devices using tissues of animal origin: we have the expertise you need, led by the Convenor of ISO/TC 194/WG 19: Tissue Product Safety working group. ✔️The device containing medicinal substances: understand the borderlines and implications, let NAMSA simplify regulatory complexities for combination products, and earn your CE Mark more efficiently. ✔️UKCA Marking: Our UK-based experts support understanding and navigating the new regulatory framework, and whether UKCA or CE is best for your device. ❕Engage with NAMSA's CE Mark consultants today and learn how we can help you achieve your goals efficiently and effectively: 👉https://lnkd.in/eT4jM3w

CE Mark Consulting: NAMSA's Comprehensive Solutions🔎 Obtaining a CE Mark for your medical device can be complex and involves several regulatory hurdles to navigate. Whether you are embarking on your first device to be CE marked or taking your device portfolio through the transition to the MDR, with a global team of regulatory consultants, made up of former Notified Body staff and experts, NAMSA offers extensive consulting services to guide you on this intricate path. ✔️Regulatory/clinical strategy including classification: Find the most expedient pathway to CE marking under the MDR. ✔️Development and compilation of technical documentation, including: ◾️ISO 14791 risk management. ◾️Clinical Evaluation Plan and Report (CEP/CER) ◾️Post Market Clinical Follow-Up (PMCF) strategy and implementation ◾️Summary of Safety and Clinical Performance (SSCP) ✔️Development and implementation of Quality Management Systems (QMS) to meet MDR and ISO13485:2016 requirements. ✔️Full biocompatibility services under ISO 10993. ✔️Selection of Notified Body (NB) and ongoing engagement: our ex-NB experts have the experience that can make a difference. ◾️Leading/support in calls/meetings with notified bodies ◾️Non-conformity analysis, advice, resolutions ✔️Devices using tissues of animal origin: we have the expertise you need, led by the Convenor of ISO/TC 194/WG 19: Tissue Product Safety working group. ✔️The device containing medicinal substances: understand the borderlines and implications, let NAMSA simplify regulatory complexities for combination products, and earn your CE Mark more efficiently. ✔️UKCA Marking: Our UK-based experts support understanding and navigating the new regulatory framework, and whether UKCA or CE is best for your device. ❕Engage with NAMSA's CE Mark consultants today and learn how we can help you achieve your goals efficiently and effectively: 👉https://lnkd.in/eT4jM3w

🔬 Exciting News Alert! 🔬 I am thrilled to share that I recently had the opportunity to participate in a highly informative webinar hosted by RAPS (Regulatory Affairs Professionals Society) on the intricacies of 510(k) submissions for medical devices! 🏥💡 The session was incredibly enlightening, delving deep into the nuances of the submission process, regulatory requirements, and best practices for ensuring compliance with the FDA guidelines. The expert panelists provided invaluable insights, shedding light on the latest trends, challenges, and success strategies in the ever-evolving landscape of medical device regulations. 🌐💊 Here are the key takeaways: 🔹 Understanding the critical components of a successful 510(k) submission. 🔹 Navigating the regulatory hurdles and compliance essentials. 🔹 Real-world case studies illustrating successful submissions and lessons learned. 🔹 Proven strategies for accelerating the approval process. 🔹 The future of regulatory landscape and anticipated changes. I am truly grateful for the opportunity to enhance my knowledge and expertise in this vital area of healthcare. Special thanks to RAPS for organizing this insightful event and to the esteemed speakers for their expertise and dedication to advancing the field of regulatory affairs. 🙌🎓 For those who missed the webinar, I highly recommend exploring RAPS resources and events to stay updated with the latest developments in regulatory affairs. Together, let's continue our journey towards ensuring the safety and efficacy of medical devices for patients worldwide. 💪🌍 Regulatory Affairs Professionals Society (RAPS) FDA #RAPS #MedicalDevices #RegulatoryAffairs #FDACompliance #HealthcareInnovation #ContinuousLearning #KnowledgeSharing #InnovationInHealthcare

Did you miss our three-part webinar series: “Cracking the Code: Demystifying EU MDR and IVDR Compliance”. Watch the recording to hear from Jacqueline van Druten - Clinical & Regulatory Affairs Director, CLIN-r+, discuss the ‘Systematic Literature Review’ section of your Technical Document for your IVDR/MDR submission and how to ensure it meets your Notified Body assessment. How to pass your Clinical Evaluation Assessment Report (CEAR): Creating a pragmatic systematic literature review process to assure EU MDR approval #EUIVDR #MedicalDevices #Embase

Are you ready for FDA Inspections? The FDA conducts various inspections on life science companies, including Surveillance inspections, for-cause inspections, and application-based inspections. These inspections are pivotal in the FDA's medical product evaluation process. Are you prepared for these crucial assessments? MEDVACON specializes in services that ensure your readiness for FDA inspections, offering FDA 483 warning letter remediation as well. Learn more at https://lnkd.in/e33YqX_J. #inspectionreadiness #fdainspection #fda483 #warningletter #remediation #medvacon #heretohelp #gettingthingsdone #bestpractice

*Attention Laboratory Professionals: Important FDA Regulatory Update* The FDA has announced significant changes to the regulation of Laboratory Developed Tests (LDTs), which will be classified as medical devices effective May 2025. These changes will subject LDTs to increased regulatory oversight. Key changes include: Phased Implementation Timeline: From May 2025 to May 2028. Quality Management Systems: Requirements for updated systems to ensure compliance. Premarket Submission Requirements: For certain LDTs, enhancing patient safety and test reliability. These new rules will impact laboratories nationwide, presenting challenges in ensuring compliance, minimizing disruptions to patient care, and navigating complex regulations. How Doc Lab Inc Can Help:  Assess your current compliance gaps.  Develop a customized compliance strategy.  Prepare for premarket submissions.  Provide training and ongoing support. Don’t let these new regulations catch you off guard. Contact us today for a  consultation and let our experts guide you through this transition smoothly. For more detailed information on the new FDA rules and their impact on labs, read our comprehensive blog post: https://lnkd.in/gNVDynx7 #FDARegulations #LDTs #LaboratoryDevelopedTests #Compliance #PatientCare

🔍 The key to successful market entry for medical devices? Expert regulatory guidance. #RegulatoryCompliance In the dynamic landscape of medical device market entry, navigating the intricate web of global regulatory requirements is no small feat. As the VP of Your RAQA, a leading medical device regulatory consultancy, I understand that the key to triumph lies in expert guidance through the regulatory maze. 🌐 Global Expertise, Local Compliance Our team specializes in unraveling the complexities of regulatory frameworks, ensuring your medical devices meet the stringent standards set by authorities worldwide. From the rigorous demands of the US FDA to the intricacies of TGA Australian requirements, Brazil's ANVISA stipulations, Japan's MHLW prerequisites, and Health Canada's stringent standards — we've got you covered. And let's not forget the CE marking requirements for seamless entry into the European market. 🛠️ Tools and Databases for Seamless Compliance One of the cornerstones of our success is our access to cutting-edge tools and comprehensive databases. We leverage these resources to not only stay ahead of evolving regulatory landscapes but also to identify and connect with reliable suppliers for critical device components. This strategic approach ensures that every aspect of your product aligns with regulatory expectations. 🧩 Connecting the Regulatory Dots Our commitment goes beyond compliance; it's about seamlessly connecting the regulatory dots. We understand that successful market entry requires a holistic understanding of global regulatory nuances. This is where our expertise shines, ensuring that your journey from concept to market is smooth, efficient, and regulatory-compliant. 🌐 The Your RAQA Advantage ✅ Unparalleled expertise in US FDA, TGA Australia, ANVISA Brazil, MHLW Japan, Health Canada, and CE marking requirements. ✅ Access to advanced tools and databases for supplier identification and compliance tracking. ✅ Holistic regulatory guidance for seamless market entry. ✅ Comprehensive support from concept to market. 📞 When Can You Reach Out? Ready to embark on a successful market entry journey? Contact us at your.raqa@gmail.com, and let's discuss how Your RAQA can be your strategic partner in achieving regulatory compliance excellence.