confinis’ Post

Thrilled to announce the launch of confinis Academy's new video course collection! 🎉 We've worked hard to address the key challenges faced by regulatory professionals in the medical device industry. From ISO 13485 compliance to AI integration and cybersecurity, our courses are designed to empower both professionals and startups. Check them out and take advantage of our exclusive launch offers! Learn more and enroll today (links in the post below) 👇 #innovators #regulatory #compliance #andbeyond

💡 Thrilled to share this exciting news from confinis! 💡 As a proud member of the confinis team, I'm delighted to introduce confinis Academy—a game-changing e-learning platform designed to empower professionals and startups in the medical device industry. 🎯 Whether you're navigating ISO 13485 compliance, understanding global registration systems like EUDAMED, or tackling cutting-edge challenges in AI and cybersecurity for medical devices, these courses are a must-have for staying ahead in this dynamic field. 🌟 Pro Tip: Take advantage of our launch offer—25% off your first course and unlock preferred rates on our consulting services with course completion. 📚 Ready to upskill? Explore the courses here: https://lnkd.in/eCJpzXxA Let’s elevate industry knowledge together! 🚀 #RegulatoryCompliance #MedicalDevices #LearningAndDevelopment #Innovation #ConfinisAcademy

🌿Medical Device Regulation can feel like an untamed jungle, but I'll be your guide at the #MDRForum on October 10 in Mainz - coming directly from a trip to my almost second home Basel. Drawing on my experiences with BAYOOMED and BAYOOCARE in Class IIa and higher, and our hands-on work with notified bodies, I'll help you navigate the dense thicket of regulatory challenges—classification, technical documentation, cybersecurity, and more. With growing pressure on some manufacturers of Class I medical software, who are now facing stricter interpretations of MDR Rule 11, my goal is to take away the fear of the maybe unknown and give you some food for thought on how to start your own MDR adventure. So join me at the MDR Forum on October 10 when I am sharing my experience with cutting through the MDR Jungle. 🪲🦋🐊 Find out more here: https://lnkd.in/eaVbCfzb This journey will be in German, but fear not—we’ll publish a blog later on the BAYOOMED website with all the key takeaways. I look forward to your questions in the Q&A! 🎤 Standort Gesundheitswirtschaft und Biotechnologie Rheinland-Pfalz #MDR #MedicalDevices #MedTech #ConformityAssessment #DigitalHealth #MedicalApps #NotifiedBody #Conference #HereMeTalk

Immerse yourself in the realm of Post-Market Surveillance Documentation as our Celegence professionals share invaluable industry insights. Stay ahead of the curve in ensuring compliance within the medical device landscape. MDR / IVDR maintenance made easy through tech enabled services offering from Celegence. Don’t miss this chance to expand your knowledge and network with industry leaders! #PMS #PostMarketSurveillance #MedTech

🎙 𝐇𝐨𝐰 𝐭𝐨 𝐂𝐞𝐫𝐭𝐢𝐟𝐲 𝐚 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐚𝐬 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐰𝐢𝐭𝐡 𝐃𝐫. 𝐀𝐛𝐭𝐢𝐧 𝐑𝐚𝐝? (𝐓Ü𝐕 𝐒Ü𝐃) 🎙 Software as a Medical Device (SaMD) is a challenging and evolving field, especially within the EU Regulation framework. Unlike traditional medical devices, SaMD requires a nuanced approach since each software solution must be considered individually. In an Easy Medical Device Podcast episode, we invited Dr. @Abtin Rad from TÜV SÜD, a renowned expert in the field, to provide insights directly from a Notified Body. Dr. Rad discussed the complexities of SaMD certification, focusing on three key areas: ◼ SaMD Classification: Understanding the unique regulatory requirements for each software. ◼ Cybersecurity: Essential practices to safeguard patient data and device functionality. ◼ Artificial Intelligence: Addressing the specific challenges of integrating AI in medical devices. This episode is packed with valuable tips and warnings for anyone involved in the development and regulatory compliance of SaMDs. It's a must-listen for those navigating this intricate landscape! 🔗 Listen to the full episode here: https://lnkd.in/eEBXb7pn #MedicalDevices #SaMD #Cybersecurity #ArtificialIntelligence #RegulatoryAffairs #TÜVSÜD #EasyMedicalDevice #HealthcareInnovation #DigitalHealth #MedTech #HealthTech #SoftwareDevelopment #ClinicalSafety #AIinHealthcare #MedicalSoftware #Compliance

Temperature-sensitive lab samples deserve top-notch care. With LIS365’s temperature monitoring feature, ensure real-time tracking and maintain compliance effortlessly. Your samples, always protected. Learn more: www.lis365.com #LIS365 #LabInnovation #HealthcareRevolution #FutureOfLabs #EfficiencyUnlocked #laboratoryinformationsystem #labworkflows #labsoftware #labsolutions #QualityControl #LaboratorySafety #DataIntegrity #LabTechnology #StreamlinedProcesses #LaboratoryInnovation #Innovation

Yve De Buysscher, Dimitri Crelot (right), and Jean François Ladry (left) are ready at #medfit (Stand A14) to answer all your questions about Qity's range of services in Quality Assurance, Regulatory Affairs, Safety Testing, Architecture & Design, Cybersecurity & Data Privacy, Usability Engineering, and Clinical Operations. Come say Hello and check out in person how to increase efficiency and reduce costs in your manufacturing with Qity's Manufacturing Execution System!

🔎 In this case study, read how xDome's robust device discovery, #VulnerabilityManagement capabilities, and ability to work seamlessly with a variety of medical device manufacturers influenced one of America’s top-ranked academic health centers to implement Claroty xDome for Healthcare to their network of hospitals and #healthcare facilities. https://hubs.li/Q02PMYKX0

AxIT Features - Copy and paste testing data into your PMS with AxIT Connect. We know the feeling. You've just finished 8 hours straight looking after clients and you now need to write all your notes before you can finally head home. That's why AxIT Connect helps save valuable admin time every day with one click copy and paste of your AxIT Testing data into your PMS. 15 minutes a day could save you an entire week a year! Upgrade your services and make them more time-efficient with AxIT. Go to www.strenghtbynumbers.com to learn more. #axit #assessment #healthtech #physiotech #notetaking #cliniko #nookal #pracsuite #halaxy #strengthtesting #performancetesting #physio #exercisephysiology

YODD – Your Online Doctor Diagnostics - BeKey Summary: #YODD: Your Online Doctor Diagnostics is a revolutionary platform that leverages technology to provide remote healthcare services. With #Telemedicine, patients can consult with doctors online, access medical records securely, and receive prescriptions electronically. The platform also offers #RemoteMonitoring tools for patients with chronic conditions, allowing for continuous care and timely interventions. #AI algorithms analyze medical data to assist healthcare providers in making accurate diagnoses and treatment recommendations. #Cybersecurity measures are in place to protect patient information and ensure compliance with privacy regulations. YODD is shaping the future of healthcare delivery by merging technology and medicine seamlessly. #Telemedicine: YODD enables patients to consult with healthcare providers remotely, eliminating the need for in-person visits. This convenient ai.mediformatica.com #health #healthcare #data #doctor #about #medical #telehealth #acce #connect #diagnostic #healthdata #privacy #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/4bWW6Az)