Qity’s Post

🎙 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

Thomas Doerge from BSI is sharing insights about the regulatory framework for SaMD products, especially those utilizing AI, and addresses critical cybersecurity considerations for AI-based medical devices. His presentation explores the role of notified bodies in ensuring that AI-driven medical software is safe, effective, and secure. #ConnectedCombinedProducts #MPP2024 #Pharma #Medtech #solutions

Building Med-Tech solutions is hard work... From demanding technical and security requirements to accreditation and then actually delivering it and managing in-field issues, There's always plenty to keep the solution and delivery team busy. They say a problem shared, is a problem halved... So what are the biggest challenges that you're facing today? Drop a note in the comments below with what's causing you the biggest headache at the moment. #medtech #innovation #solutiondelivery

Day 1 at Med-Tech Innovation 🤩 come and say hi 👋 and find out how Periculo and Harpe can help you with your medical security and compliance needs 🙌🏼

It's estimated that upwards of 8% of medical devices globally are fraudulent. An increasingly complex global supply chain means that traditional authentication and tracing methods such as serial numbers and barcodes no longer work in today’s environment – opening the door for fraud in an industry where the consequences can be a matter of life or death. On Thursday, our CEO Roei Ganzarski will be presenting “Stopping Fraudulent Medtech Starts at the Manufacturing Level” at the MEDevice conference in Santa Clara at 2:15pm PST. He will address how technologies like FeaturePrint can safeguard patient health and safety, deter fraud, and boost consumer confidence, strengthening trust in the healthcare system. In an industry where technological advancements are reshaping the landscape daily, the need for anti-fraud solutions has never been more critical. From production to patient, FeaturePrint guarantees that every product is what it claims to be, delivering unmatched trust and security at every touchpoint. https://lnkd.in/gzQ_yiur #Alitheon #FeaturePrint #OpticalAI #Innovation #TechSolution #Counterfeits #Authentication #FightFakes #CounterfeitMedicine #FakeMedicalDevices #MEDevice

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We had so much success, can we have 100x more, please? One of the most time-consuming, tediously tactical tasks in contact centers (heck, for everyone) is conversation wrap-up. What if contact center agents had an assistant to do it for them? Automagically? Immediately? Think about how that would free them up to take another call from a patient, someone in need of support... AI used the right way can have dramatic positive business outcomes and exponential human impact.

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📚 Silent (R)Evolution 💡 Download your copy here: https://bit.ly/3WwRHOx to discover how to achieve: ✅ Efficiency and collaboration improvements ✅ Early problem identification and correction ✅ #Virtualprototyping and design optimization ✅ Right-the-first-time regulatory compliance Enjoy your read! #NVH #Acoustics #VAOne #SimulationSoftware