Easy Medical Device

🔍 𝐀𝐮𝐝𝐢𝐭 𝐯𝐬. 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧: 𝐒𝐭𝐢𝐥𝐥 𝐜𝐨𝐧𝐟𝐮𝐬𝐞𝐝? 𝐘𝐨𝐮’𝐫𝐞 𝐧𝐨𝐭 𝐚𝐥𝐨𝐧𝐞 In the medical device world, compliance isn’t just a checkbox—it’s survival. Yet many still mix up audits and inspections like they're twins… Spoiler alert: They’re not. ❌👯♀️ 🧠 𝐈𝐧 𝐨𝐮𝐫 𝐥𝐚𝐭𝐞𝐬𝐭 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐍𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫, 𝐰𝐞 𝐛𝐫𝐞𝐚𝐤 𝐢𝐭 𝐚𝐥𝐥 𝐝𝐨𝐰𝐧: ✅ What’s the real difference between an audit and an inspection ✅ Who conducts them, when, and why ✅ How to get your team audit- and inspection-ready ✅ What happens if you’re NOT prepared (hint: it’s not pretty) 💡 Plus, we’ve got expert insights from names like Dr. Vikas Ghattargi, @Jennie Clark , and Rajha Rajamurthi on how to navigate both processes without panic. 🎙️ Don’t miss this week’s podcast on the Top 3 FDA Inspection Issues 📘 Read our blog on preparing for your Notified Body audit 📎 Download tools to help with MDSAP audits and EMDN classification 🛡️ Compliance is a process. Let us help you master it. 👇 Read the full newsletter and share your biggest audit/inspection horror story in the comments! #MedicalDevices #Compliance #Audits #Inspections #QualityAssurance #MDR #IVDR #ISO13485 #EasyMedicalDevice #Newsletter

🚨 𝐍𝐞𝐰 𝐄𝐌𝐃𝐍 𝐔𝐩𝐝𝐚𝐭𝐞 𝐑𝐞𝐥𝐞𝐚𝐬𝐞𝐝 – 𝐇𝐞𝐫𝐞’𝐬 𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐊𝐧𝐨𝐰! 🩺 The MDCG has published an updated version of the FAQ on the European Medical Device Nomenclature (EMDN) (MDCG 2021-12 Rev.1 – January 2025) 📅 This revision brings a more structured approach and adds 18 new questions to clarify: ✅ How to assign the most specific EMDN code to your device (UDI-DI) ✅ When and how to use the "99 – Other" fallback code ✅ What to do during the annual EMDN update process ✅ Your responsibilities as a manufacturer or economic operator ✅ How to stay compliant before your next surveillance audit 🔍 Whether you’re a manufacturer, regulatory professional, or part of a notified body, this update directly impacts your EUDAMED entries and documentation. 👉 Read our full summary and access the official MDCG document here: https://lnkd.in/dMHCyNss #MedicalDevices #EMDN #EUDAMED #MDR #IVDR #RegulatoryAffairs #UDI #Compliance #MedTechUpdate #EasyMedicalDevice

🚀 𝐌𝐃𝐒𝐀𝐏 𝐆𝐚𝐩 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐓𝐨𝐨𝐥: 𝐘𝐨𝐮𝐫 𝐏𝐚𝐭𝐡 𝐭𝐨 𝐌𝐃𝐒𝐀𝐏 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧! Ready to be MDSAP certified? Our MDSAP Gap Assessment Tool provides you with all the requirements you need to comply with across 7 key chapters. With specific regulations for 5 countries—Australia 🇦🇺, Brazil 🇧🇷, Canada 🇨🇦, Japan 🇯🇵, and the USA 🇺🇸—you’ll be well-prepared for your MDSAP audit. ✨ Key Features: Comprehensive requirements for each country Access to official regulations for clarity Covers essential topics: Management, Design, Development, Production, Purchasing, and more Prepare your team with training before and after certification 📋 Why Choose Us? Simplify your MDSAP audit preparation Stay compliant and up-to-date with regulatory standards Expert training and support to guide you every step of the way 📩 Need assistance? Contact us at info@easymedicaldevice.com for personalized support or training! 🔖 #MDSAP #MedicalDeviceCompliance #AuditPrep #Certification #QualityManagement #EasyMedicalDevice #RegulatoryCompliance #MDSAPCertified

🚀 𝐌𝐚𝐬𝐭𝐞𝐫 𝐈𝐒𝐎 13485 𝐟𝐫𝐨𝐦 𝐓𝐡𝐞𝐨𝐫𝐲 𝐭𝐨 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞! 🚀 📍 𝐑𝐚𝐛𝐚𝐭, 𝐌𝐨𝐫𝐨𝐜𝐜𝐨 📅 9-10 𝐀𝐩𝐫𝐢𝐥 2024 Are you ready to take your Quality Management System (QMS) expertise to the next level? Whether you're a quality professional, medical device manufacturer, or a student looking to build a strong foundation in ISO 13485, this training is for you! 🔍 𝐖𝐡𝐚𝐭’𝐬 𝐢𝐧 𝐢𝐭 𝐟𝐨𝐫 𝐲𝐨𝐮? ✅ 𝘋𝘦𝘦𝘱 𝘥𝘪𝘷𝘦 𝘪𝘯𝘵𝘰 𝘐𝘚𝘖 13485 𝘴𝘵𝘳𝘶𝘤𝘵𝘶𝘳𝘦 & 𝘳𝘦𝘲𝘶𝘪𝘳𝘦𝘮𝘦𝘯𝘵𝘴  ✅ 𝘏𝘢𝘯𝘥𝘴-𝘰𝘯 𝘸𝘰𝘳𝘬𝘴𝘩𝘰𝘱𝘴 (𝘊𝘈𝘗𝘈, 𝘤𝘰𝘮𝘱𝘭𝘢𝘪𝘯𝘵 𝘩𝘢𝘯𝘥𝘭𝘪𝘯𝘨, 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵𝘢𝘵𝘪𝘰𝘯)  ✅ 𝘐𝘯𝘴𝘪𝘨𝘩𝘵𝘴 𝘪𝘯𝘵𝘰 𝘢𝘶𝘥𝘪𝘵 𝘱𝘳𝘦𝘱𝘢𝘳𝘢𝘵𝘪𝘰𝘯 𝘢𝘯𝘥 𝘤𝘰𝘮𝘮𝘰𝘯 𝘱𝘪𝘵𝘧𝘢𝘭𝘭𝘴  ✅ 𝘎𝘶𝘪𝘥𝘢𝘯𝘤𝘦 𝘰𝘯 𝘤𝘦𝘳𝘵𝘪𝘧𝘪𝘤𝘢𝘵𝘪𝘰𝘯 & 𝘯𝘰𝘵𝘪𝘧𝘪𝘦𝘥 𝘣𝘰𝘥𝘺 𝘦𝘹𝘱𝘦𝘤𝘵𝘢𝘵𝘪𝘰𝘯𝘴 👥 𝐖𝐡𝐨 𝐬𝐡𝐨𝐮𝐥𝐝 𝐚𝐭𝐭𝐞𝐧𝐝? 🔹 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 & 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬 looking to enhance their expertise 🔹 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 aiming for compliance 🔹 𝐒𝐭𝐮𝐝𝐞𝐧𝐭𝐬 & 𝐲𝐨𝐮𝐧𝐠 𝐩𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬 seeking a competitive edge in medical device regulations 📢 𝐒𝐞𝐚𝐭𝐬 𝐚𝐫𝐞 𝐥𝐢𝐦𝐢𝐭𝐞𝐝! ecure your spot now and get ready for an interactive, practical, and career-boosting experience! 🚀 🔗 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐡𝐞𝐫𝐞: https://lnkd.in/em52sfKP 📣 𝐊𝐧𝐨𝐰 𝐬𝐨𝐦𝐞𝐨𝐧𝐞 𝐰𝐡𝐨 𝐜𝐨𝐮𝐥𝐝 𝐛𝐞𝐧𝐞𝐟𝐢𝐭? 𝐓𝐚𝐠 𝐭𝐡𝐞𝐦 𝐛𝐞𝐥𝐨𝐰! 👇 Monir El Azzouzi #ISO13485 #QualityManagement #MedicalDevices #RegulatoryCompliance #Training #EasyMedicalDevice #Certification #Students #CareerGrowth

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️ In this episode, Darrin Carlson, RAC-Devices, PMP Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned. Share this with your contacts if you know someone that would benefit from it. Check this here https://lnkd.in/eFFuWDB4 #medicaldevice #easymedicaldevice #regulatoryaffairs #podcast #startups 

📑✅ 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐭𝐞𝐚𝐦 𝐚𝐟𝐭𝐞𝐫 𝐬𝐮𝐛𝐦𝐢𝐭𝐭𝐢𝐧𝐠 𝐚𝐥𝐥 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬... 💀 But MDR has other plans! 😅 Just when you think you're done, another update is right around the corner! Who else can relate? 🤯😂 #MedicalDevices #RegulatoryAffairs #ComplianceStruggles #MDR #QualityManagement

⚠️ 𝐒𝐰𝐢𝐬𝐬𝐦𝐞𝐝𝐢𝐜 𝐏𝐌𝐒 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐒𝐭𝐚𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭 𝐨𝐫 𝐅𝐚𝐜𝐞 𝐭𝐡𝐞 𝐂𝐨𝐧𝐬𝐞𝐪𝐮𝐞𝐧𝐜𝐞𝐬! Swissmedic enforces strict Post-Market Surveillance (PMS) regulations to ensure medical device safety. 📑 ✅ Compliant Manufacturers ✔ Maintain market authorization ✔ Avoid regulatory penalties ❌ Non-Compliant Manufacturers 🚨 Risk severe penalties 🚫 Face potential market withdrawal 💡 Ignoring PMS isn’t an option! Stay ahead of Swissmedic requirements to keep your devices on the market. 👉 Read more: https://lnkd.in/er8Jx4Bt #MedicalDevice #PMS #Swissmedic #RegulatoryCompliance #Healthcare #EasyMedicalDevice #MDR #MarketAccess 🚀

🔍 𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐌𝐃𝐂𝐆 𝐔𝐩𝐝𝐚𝐭𝐞 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬! The Medical Device Coordination Group (MDCG) has released an essential guidance document to help manufacturers navigate EU MDR compliance. ✅ 𝐖𝐡𝐚𝐭’𝐬 𝐢𝐧𝐬𝐢𝐝𝐞? 📋 Key regulatory updates 🔎 Clarifications on compliance requirements 🛡️ Guidance to streamline market access 💡 𝑺𝒕𝒂𝒚 𝒂𝒉𝒆𝒂𝒅 𝒐𝒇 𝒆𝒗𝒐𝒍𝒗𝒊𝒏𝒈 𝒓𝒆𝒈𝒖𝒍𝒂𝒕𝒊𝒐𝒏𝒔—𝒎𝒂𝒌𝒆 𝒔𝒖𝒓𝒆 𝒚𝒐𝒖𝒓 𝒑𝒓𝒐𝒄𝒆𝒔𝒔𝒆𝒔 𝒂𝒍𝒊𝒈𝒏 𝒘𝒊𝒕𝒉 𝒕𝒉𝒆 𝒍𝒂𝒕𝒆𝒔𝒕 𝒔𝒕𝒂𝒏𝒅𝒂𝒓𝒅𝒔! 👉 Download now: https://lnkd.in/eS93FYj4 #MedicalDevice #MDCG #MDR #RegulatoryCompliance #EURegulations #EasyMedicalDevice #MedicalDeviceIndustry 🚀

- eIFU proposal until March 21st- eIFU for professional user For full episode check: https://lnkd.in/emPA8c7J Monir El Azzouzi #easymedicaldevice #medicaldevice #regulatorycompliance

𝐈𝐬 𝐘𝐨𝐮𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐚 𝐍𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐁𝐨𝐝𝐲 𝐀𝐮𝐝𝐢𝐭? Notified Body audits can make or break your market access! 🔥 If you're navigating EU MDR or IVDR compliance, you must be prepared for rigorous audits that assess your Quality Management System, technical documentation, and Post-Market Surveillance (PMS). 🚨 What’s at stake? ❌ Delays in certification ❌ Non-compliance penalties ❌ Market access restrictions ✅ What you’ll learn in this blog: 📋 Audit Preparation: How to ensure your documentation & processes are audit-ready 🔎 Common Pitfalls: Mistakes that could jeopardize your certification 🛡️ Best Practices: Strategies to pass your audit with confidence 💡 Don’t wait until it’s too late! Discover key insights to avoid costly mistakes and streamline your audit process. 👉 Read the full guide now! https://lnkd.in/eyWFf8i #MedicalDevice #NotifiedBody #MDR #IVDR #RegulatoryCompliance #EasyMedicalDevice #QMS #QualityAssurance #AuditPreparation