TÜV SÜD - Healthcare & Medical Devices’ Post

🔎🩺Discover the key insights on Notified Body capacity and IVDR harmonization from Marta Carnielli and Andreas Stange. How is the current landscape evolving? What are the challenges and solutions? Watch our video to get the latest updates and expert advice. #IVDR #Regulation #NotifiedBody #MedTech

🔎🩺Discover the key insights on Notified Body capacity and IVDR harmonization from Marta Carnielli and Andreas Stange. How is the current landscape evolving? What are the challenges and solutions? Watch our video to get the latest updates and expert advice. #IVDR #Regulation #NotifiedBody #MedTech

Tune in to our recent MedTech Matters episode where we explore the nuances of Notified Body feedback. Our featured expert, Adrian Keene from NAMSA, provides essential tips on navigating feedback and outlining best practices for successful submissions, including: -Detailed device information -Evidence of clinical benefits -Clear safety and performance objectives 🎥 Catch the episode now and gain valuable knowledge for your regulatory strategy! https://lnkd.in/gdQYYnUG #MedTech #CEcertification #NotifiedBody #NAMSAKnows #MedicalDevices #RegulatoryAffairs

The implementation of AusUDID marks a turning point in Australian healthcare. This system aligns the nation with global standards and enhances patient safety, regulatory oversight, and market surveillance. Reed Tech has been part of an ongoing working group and is first in line to test the HL7 SPL Channel with TGA. Discover more by reading our informative blog. #AUSUDI #ReedTech #medicaldevices #regulatory https://hubs.ly/Q025N1cF0

🌐 Missed our webinar on IVDR at CACLP 2024? No problem! 🌐 We're thrilled to bring you a series of posts featuring the top questions from our "GO EU | Understanding IVDR: Analysis & Compliance Strategies" Today we focus on when to start the application process for Class C and D devices. The key takeaway? Start ASAP to avoid delays and complications, especially given the lengthy timelines required for regulatory approval.   Stay engaged as we unravel expert answers and delve deeper into the complex world of IVDR compliance. Have further questions or need personalized advice? Drop us a message at ics@inventdiagnostica.de. 🔔 Follow us for more updates and ensure you’re equipped to meet IVDR requirements efficiently! Check out our website 🌎 https://lnkd.in/dvMJXtvQ   #IVDRWebinar #CACLP #inventClinicalServices #ICS #IVDR #ClinicalResearch #ClinicalTrials

EU MDR/IVDR News! (Notified Body) Today the European Commission published an update to the document "Information on the applications for designation as a notified body - Overview of NBs at each stage of the process" For more MedTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us.   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations

Join me this Friday for an All-Expert PMS Super Roundtable 🎊 Register for the webinar here: https://lnkd.in/dY4yMW_D In view of my role at Obelis Group, I always stress the importance of monitoring EU regulatory updates closely. This Friday, I'm thrilled to join the panel where I'll discuss the recent changes and challenges in the European Medical Device Regulations. I will provide insights linked to PMS on:   1️⃣ New legacy timeline 2️⃣ MDCG Guidance 3️⃣ EUDAMED updates and its significance   Date: Oct. 27, 2023 Time: 10 AM EST - 11 AM EST / 4 PM CET - 5 PM CET / 7-30 PM IST - 8-30 PM IST Format: A LIVE, one-hour Zoom webinar Register for the webinar here: https://lnkd.in/dY4yMW_D   I encourage you to attend and learn from my fellow expert panelists: Martin King, Karandeep Singh Badwal, Marina Daineko, and Michelle Lott, RAC.   And bring your TOUGH QUESTIONS about PMS!   Plus, get the notified body perspective on PMS requirements in an exclusive new MLV interview with Marta Carnielli and Tom Patten.   Please share this announcement with your colleagues. And remember, it will be recorded, so even if you can't make it next Friday, be sure to register!   I hope you can make it!   Special thanks to Sean Smith #MedTech #EUMDR #Regulation #Webinar #postmarket #surveillance #pms #guide

📢 Navigating the complexities of the European Union Medical Device Regulation (EUMDR) is crucial for ensuring compliance and market access. 🌐 Check out our comprehensive FAQs on the classification of medical devices under EUMDR to stay informed and compliant. From understanding risk levels to ensuring proper documentation, we've got you covered! 💼🔍 #EUMDR #MedicalDevices #HealthcareCompliance #RegulatoryAffairs #MedicalDeviceRegulation #DeviceClassification #HealthcareIndustry #MedicalDeviceManufacturing #EURegulations #PatientSafety

🔬 The journey of Closed System Drug-Transfer Devices (CSTDs) reflects a significant chapter in healthcare innovation. CSTDs have revolutionized hazardous drug handling and contamination practices. 🛡️ EQUASHIELD's advancements in CSTD technology have redefined safety and efficiency, offering healthcare professionals enhanced protection in their work environment. 🌐 Discover more about the future of CSTDs and how EQUASHIELD is at the forefront of this innovation. Visit our website for further insights into our safety-first approach. https://lnkd.in/drXZUJQ #CSTDInnovation #HealthcareSafety #EQUASHIELD #FutureOfPharmacy

📰 Hot off the press! The Medical Device Coordination Group (#MDCG) just dropped a new guidance document: 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝘁𝗵𝗲 𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝘀𝘆𝘀𝘁𝗲𝗺 𝗳𝗼𝗿 𝗖𝗘-𝗺𝗮𝗿𝗸𝗲𝗱 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝗗𝗦𝗩𝗚 𝟬𝟬 - 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 (𝗗𝗦𝗩𝗚) 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲 ◾ This document aims to standardize vigilance reporting and guide manufacturers dealing with Specific Devices. ◾ Dive into the details of incident reporting, aligning with MDR and IVDR articles, and the crucial interaction with the Competent Authority. ◾ Discover the roadmap for annual revisions and the fast-track process for EMDN codes. 🔗 Official Link: https://lnkd.in/dzbMckqn Share your thoughts! Was the document helpful for you? Let's discuss! #MDCG2024 #EMDNUpdates #HealthTech #MDR #IVDR #MDSS #ECREP #Europeanmarket #Medicaldevice