📢 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
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📢 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
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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
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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
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Helping pharmaceutical company to navigate clinical trials with GxP quality, regulatory compliance and inspection readiness.
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
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On February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. In a recent blog post, Véronique L., Allyson Mullen and Ana Loloei take a deep dive into the final rule and how it affects medical device manufacturers. Read their blog post here: https://lnkd.in/g3J9pm29 #fda #medicaldevices #devices #regulatory
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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
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Regulatory Affairs Specialist Search of Biopharmaceuticals | Medical Devices | Clinical Research | Quality Assurance Co-op / Internship
🔬 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
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Every medical device manufacturer must have a quality management system in place that outlines, for example, responsibilities and requirements for risk management, product development and performance studies, market surveillance, and corrective and preventive action management (CAPA). In this webinar, we'll look together at the challenges manufacturers face and the biggest sources of mistakes when transitioning to the MDR. Here the full agenda of the webinar: • Classification under the Medical Device Regulation • Structure of technical documentation compared to the MDD • Correct labeling • Validation of stability data • Risk management • Post-market surveillance Click here to watch the webinar: 👉https://lnkd.in/dXbCAKVf
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🔬 Attention Clinical Researchers! 🔬 Explore the future of FDA regulatory assessments with our latest blog post on Remote Regulatory Assessments (RRAs). 💡 Gain insights into the efficiency, reduced travel, and global reach benefits of RRAs compared to traditional inspections 📖 Learn essential preparation steps and discover how CRIO can elevate compliance and streamline document management for smoother interactions with regulatory agencies. Stay ahead in the clinical trials landscape. Read the full post now: bit.ly/3Tq84MD #ClinicalResearch #FDA #RRAs #Compliance #CRIO #ClinicalTrials #RegulatoryAssessments #Innovation
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