Easy Medical Device

🔴𝐍𝐞𝐰 𝐄𝐔𝐃𝐀𝐌𝐄𝐃 𝐔𝐬𝐞𝐫 𝐆𝐮𝐢𝐝𝐞 𝐑𝐞𝐥𝐞𝐚𝐬𝐞𝐝: 𝐍𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐁𝐨𝐝𝐢𝐞𝐬 𝐚𝐧𝐝 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐞𝐬 🔴 The European Commission published the updated EUDAMED user guide v3.9 to help users navigate the certificate registration process for Notified Bodies within the EUDAMED platform. This guide aims to streamline compliance efforts and ensure accurate, efficient reporting. 📌 For those in regulatory roles, this is essential reading! 🔗 https://lnkd.in/eNe7kSYR #EURegulations #EUDAMED #MedicalDevices #Compliance #NotifiedBodies

✒️ 𝐋𝐞𝐠𝐚𝐜𝐲 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 𝐂𝐥𝐚𝐫𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐰𝐢𝐭𝐡 𝐌𝐃𝐂𝐆 2021-25 ✒️ The European Commission just released an update to MDCG 2021-25, bringing important clarifications for "legacy devices" under the MDR transition. Key highlights include changes to declarations of conformity, transitional provisions for systems/packs, and QMS requirements. This update ensures a smoother path to compliance while prioritizing safety. Manufacturers: time to review your documentation and QMS to stay aligned! 🚀 Read more on adapting to these changes here 👉 https://lnkd.in/ewTTGGVF #MedicalDevices #MDR #Compliance #RegulatoryAffairs #QualityManagement

🚀 𝐒𝐭𝐚𝐲 𝐀𝐡𝐞𝐚𝐝, 𝐒𝐭𝐚𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭: 𝐓𝐡𝐞 𝐕𝐢𝐭𝐚𝐥 𝐑𝐨𝐥𝐞 𝐨𝐟 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬 𝐛𝐲 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 🚀 Imagine you’re an inventor excited to launch your new medical device, the “Super Duper Health Machine.” You’ve worked hard, and the launch day is just around the corner. Everything seems perfect… until you get a call from your compliance friend. “𝘏𝘦𝘺! 𝘋𝘪𝘥 𝘺𝘰𝘶 𝘴𝘦𝘦 𝘵𝘩𝘦 𝘯𝘦𝘸 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘪𝘰𝘯𝘴? 𝘛𝘩𝘦 𝘯𝘰𝘵𝘪𝘧𝘪𝘦𝘥 𝘣𝘰𝘥𝘺 𝘫𝘶𝘴𝘵 𝘳𝘦𝘭𝘦𝘢𝘴𝘦𝘥 𝘴𝘰𝘮𝘦 𝘭𝘢𝘴𝘵-𝘮𝘪𝘯𝘶𝘵𝘦 𝘶𝘱𝘥𝘢𝘵𝘦𝘴!” 😱 Panic sets in as you picture your launch plans falling apart. But then, you remember your secret weapon: 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬 𝐛𝐲 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞! They’re like your trusty sidekick, always updated on the latest regulations. With their help, you quickly adjust your plans to meet the new guidelines. You’re back on track and ready to launch on time! 🎉 Thanks to Easy Medical Device’s Regulatory Intelligence Services, you not only stay compliant but also keep your innovative spirit alive. So, if you want to drive innovation and access new markets, staying ahead with regulatory insights is key! 🌐💡 Let’s embrace the power of proactive compliance together! 🔗 https://lnkd.in/gvN9sY5d #RegulatoryIntelligence #ComplianceAdvantage #InnovationLeadership #EasyMedicalDevice

🌟 𝐄𝐱𝐜𝐢𝐭𝐢𝐧𝐠 𝐍𝐞𝐰𝐬 𝐟𝐫𝐨𝐦 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞! 🌟 Our latest edition of 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐍𝐄𝐖𝐒 is out now! 🎉 This week, we dive deep into the financial aspects of preparing for EU MDR compliance. 💶 𝐖𝐡𝐚𝐭 𝐭𝐨 𝐄𝐱𝐩𝐞𝐜𝐭: ◼️ Insightful breakdown of Notified Body Fees and how to budget effectively. ◼️ The costs associated with gathering Clinical Data and updating your Quality Management System (QMS). ◼️ Strategies for team training and ensuring documentation meets the rigorous MDR standards. 🔍 We’ve also included the latest regulatory updates, a humorous meme of the week, and details about our participation in the upcoming AffriSummit 2024 in Cairo! 👉 Don’t miss out on essential insights that can help your organization navigate the complex landscape of medical device regulations. 📰 Read the full newsletter here Stay informed and compliant—let's tackle these challenges together! 🚀 #MedicalDevices #EUMDR #Compliance #HealthcareInnovation #EasyMedicalDevice #Newsletter

♦️ What is Regulatory Lasagna? A Fun Take on Compliance For full episode, check: https://lnkd.in/gmEis8dg Monir El Azzouzi Adam Isaacs Rae #ComplianceStrategy #ProductCompliance #RiskManagement #RegulatoryCompliance

🎧 𝐌𝐚𝐬𝐭𝐞𝐫𝐢𝐧𝐠 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐢𝐨𝐧𝐬: 𝐒𝐩𝐨𝐧𝐬𝐨𝐫, 𝐒𝐮𝐛𝐣𝐞𝐜𝐭, 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞, 𝐚𝐧𝐝 𝐌𝐨𝐫𝐞! 🔍 In this episode, we break down the essential terms that every MedTech professional needs to know about clinical investigations. Whether you're navigating compliance or just brushing up on your knowledge, we’ve made it simple: 💡 𝘚𝘱𝘰𝘯𝘴𝘰𝘳 – 𝘞𝘩𝘰’𝘴 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘪𝘣𝘭𝘦 𝘧𝘰𝘳 𝘪𝘯𝘪𝘵𝘪𝘢𝘵𝘪𝘯𝘨 𝘢𝘯𝘥 𝘧𝘪𝘯𝘢𝘯𝘤𝘪𝘯𝘨? 💡 𝘚𝘶𝘣𝘫𝘦𝘤𝘵 – 𝘞𝘩𝘰'𝘴 𝘵𝘩𝘦 𝘣𝘳𝘢𝘷𝘦 𝘱𝘢𝘳𝘵𝘪𝘤𝘪𝘱𝘢𝘯𝘵? 💡 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘌𝘷𝘪𝘥𝘦𝘯𝘤𝘦 – 𝘛𝘩𝘦 𝘱𝘳𝘰𝘰𝘧 𝘣𝘦𝘩𝘪𝘯𝘥 𝘵𝘩𝘦 𝘴𝘢𝘧𝘦𝘵𝘺 𝘢𝘯𝘥 𝘦𝘧𝘧𝘦𝘤𝘵𝘪𝘷𝘦𝘯𝘦𝘴𝘴. 💡 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘗𝘦𝘳𝘧𝘰𝘳𝘮𝘢𝘯𝘤𝘦 – 𝘏𝘰𝘸 𝘸𝘦𝘭𝘭 𝘵𝘩𝘦 𝘥𝘦𝘷𝘪𝘤𝘦 𝘱𝘦𝘳𝘧𝘰𝘳𝘮𝘴 𝘪𝘵𝘴 𝘫𝘰𝘣. 💡 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘉𝘦𝘯𝘦𝘧𝘪𝘵 – 𝘛𝘩𝘦 𝘱𝘰𝘴𝘪𝘵𝘪𝘷𝘦 𝘪𝘮𝘱𝘢𝘤𝘵 𝘰𝘯 𝘩𝘦𝘢𝘭𝘵𝘩 𝘢𝘯𝘥 𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘰𝘶𝘵𝘤𝘰𝘮𝘦𝘴. 📢 Tune in to get all the insights and keep your terminology clear and compliant! #MedicalDevices #ClinicalInvestigations #RegulatoryCompliance #QualityManagement

♦️ Is One Compliance Strategy Enough for All Products? For the full episode, check: https://lnkd.in/gmEis8dg Monir El Azzouzi Adam Isaacs Rae #ComplianceStrategy #ProductCompliance #RiskManagement #RegulatoryCompliance

🚀 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐚𝐭 𝐀𝐟𝐟𝐫𝐢𝐒𝐮𝐦𝐦𝐢𝐭 2024: 𝐄𝐠𝐲𝐩𝐭, 𝐇𝐞𝐫𝐞 𝐖𝐞 𝐂𝐨𝐦𝐞! We’re thrilled to announce that Easy Medical Device will be attending the 𝐀𝐟𝐟𝐫𝐢𝐒𝐮𝐦𝐦𝐢𝐭 2024 in 𝐂𝐚𝐢𝐫𝐨! 🎉 Even more exciting, Monir El Azzouzi will be taking the stage as a featured 𝐬𝐩𝐞𝐚𝐤𝐞𝐫! 🎤 Get ready for groundbreaking insights into medical device innovation, regulatory strategies, and how to navigate the evolving landscape of the African market. 🌍 📅 𝐖𝐡𝐞𝐧: 3-6 November 2024 📍 𝐖𝐡𝐞𝐫𝐞: Cairo, Egypt We can't wait to connect, share, and explore new opportunities in this dynamic region! 🌟 #AffriSummit2024 #EasyMedicalDevice #MedicalDevices #RegulatoryAffairs #AfricaMedTech #Compliance

🎙️ 𝐏𝐨𝐝𝐜𝐚𝐬𝐭 𝐄𝐩𝐢𝐬𝐨𝐝𝐞: 𝐖𝐡𝐲 𝐢𝐬 𝐢𝐭 𝐢𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐟𝐨𝐫 𝐚𝐧 𝐈𝐦𝐩𝐨𝐫𝐭𝐞𝐫 𝐭𝐨 𝐛𝐞 𝐈𝐒𝐎 13485 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝? 🏆 When we think of ISO 13485, it’s often linked to manufacturers, but it’s just as crucial for Medical Device Economic Operators like importers and distributors. In this episode, Cristina Miroescu (Compliance Director at SOFMEDICA Life-saving Innovation) shares their journey to ISO 13485 certification, discussing the pros and cons along the way. 🌟 🎧 Watch the full episode: https://lnkd.in/eMuaww7N #ISO13485 #MedicalDevices #Compliance #QualityManagement #Importer

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️ Do you know what is a Strategy for Regulatory Compliance? If you even never heard about it then you are in trouble. This is a requirement of the EU MDR and IVDR to have one but now the question is how to make it and what to be inside? So let’s review that with Adam Isaacs Rae and Monir El Azzouzi Check this here https://lnkd.in/gmEis8dg Monir El Azzouzi Adam Isaacs Rae #medicaldevice #easymedicaldevice #regulatoryaffairs #podcast #regulatorycompliance