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📍June 11, @ 3 pm CEST/ 9 am EDT 📍 This upcoming webinar with our partner 1MED SA, will explore the complexities of the EU MDR journey by deep diving into its multifaceted challenges and emphasizing the pivotal year of 2024 for the MedTech industry. Attendees will acquire valuable insights into regulatory compliance, best practices for clinical data collection, market entry strategies, and the evolving MedTech regulatory landscape. Specifically, the webinar will cover: 📌 MDR: What a challenging journey 📌 The importance of 2024 in MedTech 📌 EU market as first choice? 📌 How to navigate current and future regulatory challenges 📌 Best practices for clinical data collection Register for the webinar: https://hubs.ly/Q02yBGhC0 #eumdr #mdr #medicaldevices #regulations #medtech #webinar #mdrdeadline #greenlightguru

🌟 Exciting Panel Announcement! 🌟 Meet Russell, our panel member for MIC's Biggest Conversation! 🎙️ Currently leading at the Medicines and Healthcare products Regulatory Agency (MHRA), Russell spearheads the regulation of Artificial Intelligence as a Medical Device (AIaMD). Get ready for an insightful discussion as Russell shares his wealth of knowledge at MIC's Biggest Conversation! 🗣️ #MICsBiggestConversation #AIinMedicine #PanelSpeaker #AIEvent #Maidstone 🚀

🎉 Exciting Announcement: "MDCG 2024 – Insights by Theme" 🎉 This year has been highly productive for EU medical device regulations, with new MDCG guidelines offering valuable clarity and direction for the industry. 💡 Why This Series? To help you stay informed and compliant, I’m launching a thematic series that organizes all MDCG documents published in 2024 by key topics. 🔍 What’s Inside: 🎯 Focused themes: Clinical, Post-Market, vigilance, CAPA and more. ♦️Actionable takeaways designed for medical device professionals. ♦️Simplified insights to streamline your regulatory practices. Stay tuned for the first theme:  🚀 Clinical Guidance 🚀

The first half of this year has brought several important regulatory changes. In this installment of our Regulatory Rundown, we cover updates from the Medical Device Coordination Group (MDCG) on vigilance terms and concepts under Regulation (EU) 2017/745 (MDR). Stay tuned for more news, expert analysis, and industry insights in our MedTech Navigator series. #MedTech #MedTechNavigator #RegulatoryRundown #RegulatoryUpdates #ClinicalTrials #MedicalDevices #CogenTech

MEDIcept Minute: NOW AVAILABLE: Voluntary Use of eSTAR for 513(g) Requests for Information Exciting news alert! The FDA's electronic Submission Template And Resource (eSTAR) is now available for voluntary use for 513(g) requests for information to CDRH. This interactive PDF form guides applicants through preparing a comprehensive medical device submission, ensuring quality and completeness. As we continue to navigate the dynamic landscape of medical device regulation, tools like eSTAR become invaluable for efficient premarket reviews. Read more about this announcement from FDA at the link below: https://lnkd.in/gEg8p-jP At MEDIcept Inc., we're committed to supporting industry professionals in staying ahead of regulatory advancements. Contact [email protected] TODAY for expert advice tailored to your needs. Let's elevate the standards of medical device submissions together! #FDA #MedicalDevice #RegulatoryCompliance #eSTAR #MediceptAdvice  

Here you go! This is the first of our Medtech Navigatie series. Enjoy the quick update. See you soon at #tct2024

The World Health Organization has released the latest version of its Global Benchmarking Tool Plus Medical Devices (GBT+MD), a valuable resource designed to strengthen national regulatory systems for medical devices, including in-vitro diagnostics. Published in December 2024, this updated version (Revision VI+MD version 2) introduces six essential regulatory functions and includes a user-friendly glossary and fact sheet to support understanding. Currently available in English, efforts are underway to translate it into other UN languages to ensure accessibility for all. For more details or access to the computerized platform (cGBT), the WHO Regulatory Systems Strengthening Team is happy to assist at [email protected]. Read more: https://lnkd.in/ejseGSYy

REGISTER NOW! Despite considerable progress in transitioning to the IVD rules introduced in 2017, and the additional time given to implement them, progress in the sector remains slow. Now in 2024 further steps are being proposed to ensure the availability of certain IVDs, accelerating the sector’s progress towards the transition. Join our webinar with experts representing notified bodies, industry and legal establishments for the latest update on IVDR and what it means for you. Register here: https://hubs.li/Q02pNZHg0

Would you like to bring your medical device to the European market? As your reliable regulatory partner, we will help you navigate the complex MDR environment and identify and prioritize requirements, build a strategy, and implement the scientific requirements. Connect with Tabatha Bourgois next week at #BIO2024 to learn more about our capabilities, and download our MDR Preparedness Checklist here: https://lnkd.in/efxku9Vj #medicaldevices

Navigating Global Med-Tech Trials: Best Countries to Consider We explore the best countries for streamlining med-tech clinical trials beyond Latin America. Discover why Eastern Europe remains a hot spot and how new EU regulations may impact medical device approvals. Stay ahead in the ever-evolving med-tech landscape! #MedTech #ClinicalTrials #MedicalDevices #EUMDR #Regulations #HealthcareInnovation #EasternEurope #LatinAmerica #GlobalHealth #MedTechTrends