NAMSA’s Post

🎉 Exciting News in the Regulatory Landscape! 🌍✨ Thrilled to share the latest insights from the EU Commission's Medical Device Coordination Group (MDCG) Position Paper! 📄🇪🇺 OMC Medical is committed to keeping you informed and empowered in the ever-evolving regulatory landscape. 🔍 Key Highlights The MDCG Position Paper issues a crucial notice to manufacturers and notified bodies, emphasizing the imperative of timely compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements. 🚀💡 Ensuring adherence to these standards is paramount for the success and sustainability of our industry. 🌐 Global Impact As the healthcare industry continues to advance, global harmonization of regulations becomes increasingly vital. The MDCG's guidance aligns with OMC Medical's commitment to upholding the highest standards, fostering innovation, and prioritizing patient safety worldwide. 🚀 OMC Medical's Pledge We are dedicated to proactively meeting and exceeding regulatory expectations. OMC Medical places paramount importance on compliance, quality, and customer satisfaction. Our team is ready to navigate these changes, ensuring seamless transitions for our partners and clients. 🚨 Stay Informed, Stay Ahead To stay at the forefront of industry developments, it's essential to stay informed and engaged. Let's navigate this journey together! 🙌 Thank You A special thank you to the EU Commission and MDCG for their ongoing efforts to strengthen the regulatory framework. OMC Medical is proud to be part of a community dedicated to advancing healthcare solutions responsibly. https://lnkd.in/dtrPzRii #OMCMedical #RegulatoryExcellence #HealthcareInnovation #ComplianceMatters #MedicalDeviceRegulation #IVDRegulation #EUCommission #MDCG #MDR #IVDR 🎉 Join the conversation and share your thoughts below! Let's drive positive change in the healthcare landscape together. 💬👥

Learn about the critical role of the FDA's MedWatch program in monitoring the safety of medical devices and other FDA-regulated products. Our latest blog explains the importance of adverse event reporting, how to effectively use the MedWatch form, and the impact of this program on patient safety and regulatory compliance. Stay informed and ensure your reporting processes are up to date 🔗 : https://lnkd.in/eC_KGNaD #MatrixRequirements #MedWatch #FDA #MedicalDevices #PatientSafety #RegulatoryCompliance

📣 Join us for an insightful webinar on Post-Market Clinical Follow-up (PMCF) in Action: A Practical Approach to EU MDR Compliance! 🌟 Sponsored content from NAMSA: 🗓️ Date: June 20, 2024 ⏰ Time: 10:00 AM - 11:00 AM CT 📝 REGISTER NOW: https://bit.ly/452kVZr Join our webinar to delve into PMCF intricacies under the EU MDR. We'll cover PMCF expectations, strategy, and evidence collection, and offer real-life insights. Learn about clinical data transferability, EU country variability, and budgeting for PMCF. Key Learning Objectives: 🔹 Understanding PMCF Background and Strategy 🔹 Practical Examples and Regional Differences 🔹 Data Transferability and Budgetary Considerations #EUcompliance #MedicalDevices #MDR #PMCF #PMCFSurvey #RegulatoryAffairs #NAMSAKnows

📣 Join us for an insightful webinar on Post-Market Clinical Follow-up (PMCF) in Action: A Practical Approach to EU MDR Compliance! 🌟 🗓️ Date: June 20, 2024 ⏰ Time: 10:00 AM - 11:00 AM CT 📝 REGISTER NOW: https://lnkd.in/gSKth7uh Join our webinar to delve into PMCF intricacies under the EU MDR. We'll cover PMCF expectations, strategy, and evidence collection, and offer real-life insights. Learn about clinical data transferability, EU country variability, and budgeting for PMCF. Key Learning Objectives: 🔹 Understanding PMCF Background and Strategy 🔹 Practical Examples and Regional Differences 🔹 Data Transferability and Budgetary Considerations #EUcompliance #MedicalDevices #MDR #PMCF #RegulatoryAffairs #NAMSAKnows

Join our webinar to delve into PMCF intricacies under the EU MDR

Explore how Deviceology is revolutionising Post-Market Surveillance in the UK's medical device sector. Our latest blog post delves into the recent amendments to the UK MDR 2002 by the MHRA, aligning with ISO 13485:2016 standards. Learn how we offer comprehensive support in navigating these regulatory changes, from robust PMS plans to streamlined reporting via the new MORE portal. Stay ahead of compliance and ensure patient safety with Deviceology as your trusted partner. #UKMDR #MHRA #ISO13485 #PostMarketSurveillance

📣 Join us for an insightful webinar on Post-Market Clinical Follow-up (PMCF) in Action: A Practical Approach to EU MDR Compliance! 🌟 🗓️ Date: June 20, 2024 ⏰ Time: 10:00 AM - 11:00 AM CT 📝 REGISTER NOW: https://lnkd.in/gSKth7uh Join our webinar to delve into PMCF intricacies under the EU MDR. We'll cover PMCF expectations, strategy, and evidence collection, and offer real-life insights. Learn about clinical data transferability, EU country variability, and budgeting for PMCF. Key Learning Objectives: 🔹 Understanding PMCF Background and Strategy 🔹 Practical Examples and Regional Differences 🔹 Data Transferability and Budgetary Considerations #EUcompliance #MedicalDevices #MDR #PMCF #RegulatoryAffairs #NAMSAKnows

📣 Join us for an insightful webinar on Post-Market Clinical Follow-up (PMCF) in Action: A Practical Approach to EU MDR Compliance! 🌟 🗓️ Date: June 20, 2024 ⏰ Time: 10:00 AM - 11:00 AM CT 📝 REGISTER NOW: https://lnkd.in/gSKth7uh Join our webinar to delve into PMCF intricacies under the EU MDR. We'll cover PMCF expectations, strategy, and evidence collection, and offer real-life insights. Learn about clinical data transferability, EU country variability, and budgeting for PMCF. Key Learning Objectives: 🔹 Understanding PMCF Background and Strategy 🔹 Practical Examples and Regional Differences 🔹 Data Transferability and Budgetary Considerations #EUcompliance #MedicalDevices #MDR #PMCF #RegulatoryAffairs #NAMSAKnows

Yesterday, the EU officially adopted the proposals from 23rd January, amending the two device regulations. To recap on what we saw in January, the main gist of the proposals are as follows: ·        Prior Notification of Device Shortages Manufacturers are now required to inform their competent authority, health institutions/ professionals and relevant economic operators about pending device shortages/ supply disruptions ahead of time. This information needs to be provided at least six months prior to the expected shortage. Given how roll-out of MDR/ IVDR has gone historically, we can expect the six month timeline is going to be extremely challenging to many in industry, and we may see more on that at a later date as a consequence. ·        Updates re Eudamed Originally the use of Eudamed would not have become obligatory until all modules were audited and functional. However, the new proposals will allow for phased implementation of individual Eudamed modules once they become functional. There are also some updates re timelines on coordinated assessment of clinical investigations in Eudamed, and transfer from multiple registrations nationally to single registrations in Eudamed. ·        Updates re IVDs Transition periods for certain high risk classes of IVDs have been further extended. However, the granting of transition extensions will be only be subject to a number of conditions first being met. Check out the attached for more info, and feel free to reach out to john@atlasqualityconsultants.com if you need any help with MDR compliance. #MDR #IVDR #compliance #medicaldevices https://lnkd.in/g42rPfhG

🔍 NAMSA Blog! 🔍 Understanding the Benefit-Risk Ratio in Clinical Reports: Avoiding 6 Common Mistakes Sponsored content from NAMSA: Navigating the complexities of the EU MDR 2017/745 can be challenging, especially when it comes to benefit-risk determination. Our latest blog dives deep into the importance of this critical analysis and highlights six common mistakes to avoid. 💡 Key Takeaways: 1. Thoroughly consider the state-of-the-art to avoid skewed assessments. 2. Position your device within the medical landscape effectively. 3. Utilize both qualitative and quantitative parameters. 4. Summarize the clinical benefits clearly. 5. Discuss and assess associated risks comprehensively. 6. Conclude with a well-rounded benefit-risk ratio. At NAMSA, our experts provide invaluable insights and recommendations to ensure your Clinical Evaluation Reports (CERs) meet MDR requirements. Don't miss out on these essential tips to enhance your compliance strategy! 👉 Read the full blog here: https://bit.ly/4esCiXO #MedicalDevices #ClinicalReports #MDRCompliance #BenefitRiskAnalysis #NAMSAKnows #RegulatoryAffairs