- Would You Trust This Product for Your Family. For full episode check: https://lnkd.in/eYRtNgsx Monir El Azzouzi #easymedicaldevice #medicaldevice #regulatorycompliance
Easy Medical Device
Technologie, Information und Internet
basel, Basel Stadt 14.578 Follower:innen
Consulting Agency. Help you place your Compliant Medical Device on the market
Info
Easy Medical Device is a company that will support you to place your Medical Device on the market. With its network, the company is capable of finding you the right support you need to execute your tasks. If you have a project to develop or a problem to solve in terms of Quality and Regulatory Affairs, Easy Medical Device is your solution. We help companies that are bringing new devices on the market or companies that just need an upgrade of their system. We can also find you the right partners like European Authorized Representative or consulting firm in different countries. We can help you with the EU MDR or IVDR, the FDA QSR, the ANVISA, Health Canada... If you look to be ISO 13485 certified or even MDSAP certified then we are your partners. Easy Medical Device does have a set of tools that can also help you if you want to perform your compliance alone. Visit our shop at https://school.easymedicaldevice.com/shop to see what is available for you. Don't hesitate to contact us if you have any questions.
- Website
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https://easymedicaldevice.com
Externer Link zu Easy Medical Device
- Branche
- Technologie, Information und Internet
- Größe
- 2–10 Beschäftigte
- Hauptsitz
- basel, Basel Stadt
- Art
- Privatunternehmen
- Gegründet
- 2018
- Spezialgebiete
- Medical devices, Regulatory affairs, quality management, medical device, ISO 13485, ISO 14971, CAPA, Audits, Internal Audit, SaMD, Design Control, Compliance, European Regulation, ce marking, MDSAP, fda, EU MDR, mdr 2017/745, Medical Device Regulation, Consulting , consulting firm, Consultant, European Authorized Representative, Medtech industry, Podcast, Blog, Conference und Speaker
Orte
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Primär
Wegbeschreibung
bernouillstrasse 20
basel, Basel Stadt 4056, CH
Beschäftigte von Easy Medical Device
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Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
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Hisham Al-Qazaz
Compliance & Regulatory Affairs Manager for Kimal
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Mateus Lima
Regulatory Affairs | Quality Assurance | Medical Device Specialist | ISO 13485 | ISO 14971 | EU.MDR 17.745
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Neelimanair Kallayila
QA RA Engineer| Authorised representative & Importer service | Medical device regulation EU MDR 2017/745| Labelling & IFU
Updates
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🚀 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐊𝐞𝐲 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 & 𝐓𝐫𝐞𝐧𝐝𝐬 🚀 In this week's Easy Medical Device newsletter, we explore the critical role of companion diagnostics (CDx) in personalized medicine and their regulatory journey under the IVDR. We also highlight emerging trends, including AI-driven diagnostics and the future of advanced therapies. 🧬 Plus, discover essential tips for ISO 13485 compliance, software validation, and audit readiness. Our latest podcast offers valuable insights for startups in the medical device industry. 🎧 Stay updated with expert advice and strategies to navigate the evolving landscape of medical device regulation. 💡 #MedicalDevices #CompanionDiagnostics #PersonalizedMedicine #RegulatoryCompliance #EasyMedicalDevice
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- Your Guide to Medical Device Success! For full episode check: https://lnkd.in/eYRtNgsx Monir El Azzouzi #easymedicaldevice #medicaldevice #regulatorycompliance
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🎥 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐂𝐨𝐦𝐦𝐨𝐧 𝐒𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐢𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 🏥 In this video, I explain the importance of Common Specifications (CS) in medical device regulation and how they help ensure safety and performance. ✅ Learn how manufacturers can comply with regulatory standards or adopt alternative solutions to maintain high quality. 🔍 If you're in the medical device industry, this is a must-watch! 🌐 #MedicalDevices #Regulation #Compliance #CommonSpecifications #HealthTech
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𝐁𝐞𝐟𝐨𝐫𝐞 𝐚𝐧𝐝 𝐀𝐟𝐭𝐞𝐫: 𝐓𝐡𝐞 𝐏𝐨𝐰𝐞𝐫 𝐨𝐟 𝐚 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐑𝐞𝐯𝐢𝐞𝐰 𝐛𝐲 𝐄𝐚𝐬𝐲 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞✨ Are you feeling overwhelmed by unorganized processes, piles of paperwork, and inefficiency in your organization? 🚨 ✨ Before: Chaos. Missed opportunities. Unclear strategies. ✅ After: Efficiency. Focused leadership. Clear, actionable strategies for growth. At Easy Medical Device, our Management Review Service transforms your operations by assessing your managerial processes, ensuring effective decision-making, and improving overall efficiency. We help you stay focused on your key activities while driving performance and compliance. Let us help you move from chaos to clarity! 📩 Contact us today to learn more: info@easymedicaldevice.com #ManagementReview #EasyMedicalDevice #Compliance #Leadership #Efficiency #MedicalDevices #BusinessTransformation
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🎧𝐌𝐚𝐬𝐭𝐞𝐫𝐢𝐧𝐠 𝐏𝐌𝐂𝐅 𝐋𝐢𝐭𝐞𝐫𝐚𝐭𝐮𝐫𝐞 𝐒𝐞𝐚𝐫𝐜𝐡: 𝐄𝐱𝐩𝐞𝐫𝐭 𝐓𝐢𝐩𝐬 𝐭𝐨 𝐆𝐞𝐭 𝐈𝐭 𝐑𝐢𝐠𝐡𝐭 𝐰𝐢𝐭𝐡 𝐂𝐞𝐬𝐚𝐫𝐞 𝐌𝐚𝐠𝐫𝐢📚 Join Cesare Magri, Founder & CEO of 4BetterDevices GmbH, as he clears up common misconceptions and shares expert tips on conducting an effective PMCF literature search for medical devices. With over 100 evaluations in his portfolio, Cesare offers invaluable insights to help you perfect your PMCF process. 🎙️ Tune in now for essential tips to improve your skills! https://lnkd.in/eWRu-XZg #PMCF #MedicalDevices #MedTech #Podcast #EasyMedicalDevice #Certification
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🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️ You may be part of a Startup or work with one of them. In this episode of the podcast, Adnan Ashfaq from Simplimedica Ltd will share with us the pitfalls that can encounter some Startups. This may apply to any newcomers in the MedicaL Device Field. So, share this with your contacts if you know someone that would benefit from it. Check this here Link: https://lnkd.in/eYRtNgsx #medicaldevice #easymedicaldevice #regulatoryaffairs #podcast #startups
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Looking for healthcare, medical device, or health events around the world? 🌍 Check out MedTech Conf – they’ve got an impressive map that shows you all the different events happening globally. It's your go-to resource to stay updated on key industry happenings! 🗺️💡 🔗 https://medtechconf.com/ #MedTech #HealthcareEvents #MedicalDevices #GlobalNetworking
🎉 Join the BMES CMBE Conference 2025! 🧬 📅 Dates: January 3–6, 2025 📍 Location: Carlsbad, California, USA 💡 Theme: "Cell Engineering for Mechanomedicine and Rejuvenation" Connect with experts in biomedical engineering to explore cutting-edge advancements in cell engineering and their applications in mechanomedicine and rejuvenation. This is a perfect opportunity to expand your knowledge, engage with leaders in the field, and discover groundbreaking innovations. 🌐 Learn more and register: https://lnkd.in/eRvAw4wu Don’t miss this key event shaping the future of biomedicine! 🔬✨ #BiomedicalEngineering #CMBE2025 #Innovation #Biomedicine #Networking
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■ Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB. For full episode check: https://lnkd.in/eWeDke_c Monir El Azzouzi #easymedicaldevice #medicaldevice #regulatorycompliance
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𝐖𝐡𝐞𝐧 𝐈𝐒𝐎 13485 𝐌𝐞𝐞𝐭𝐬 𝐭𝐡𝐞 𝐋𝐞𝐚𝐝 𝐀𝐮𝐝𝐢𝐭𝐨𝐫 👀 Audits always have a way of revealing the small details we might overlook. Whether it's missing CAPA records, incomplete SOPs, or unverified processes, a robust QMS isn't just about claiming compliance—it's about being ready at all times. 💡 Lesson learned: Audit readiness means attention to detail. Stay ready, stay compliant, and don’t let the CAPA balloon float away. 🎈 #ISO13485 #MedicalDevices #QualityManagementSystem #CAPA #RegulatoryAffairs
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