Qity’s Post

🚀 The EU AI Act Goes Live Today: A New Era for Medical Devices Today marks a pivotal moment as the EU AI Act, the world’s first comprehensive artificial intelligence law, officially comes into effect! This groundbreaking regulation introduces clear and robust rules for the use of AI, with significant implications for the medical device industry. Here’s how the AI Act will shape the future of medical devices in the EU: 🔴 Unacceptable Risk AI, such as systems used for social scoring, is banned. This ensures that any AI deployed in medical devices adheres to high ethical standards and prioritizes patient safety. 🟠 High-Risk AI, including AI applications in medical devices, must comply with stringent requirements. This involves rigorous testing and validation to ensure the safety and effectiveness of these technologies in patient care. 🟡 Limited-Risk AI, like certain AI tools used for patient interaction, must inform users they are interacting with AI, enhancing transparency and trust in medical communications. 🟢 Minimal Risk AI, such as basic AI tools in medical devices, will follow existing rules with no additional obligations, maintaining a balance between innovation and regulatory oversight. The EU AI Act sets a new standard for AI deployment, fostering innovation while safeguarding public health and ethical practices. It’s a significant step towards a future where AI in medical devices is both advanced and responsibly regulated. Learn more about how the EU AI Act will impact medical devices ➡ https://lnkd.in/ehhaxR9 #EUAIAct #MedicalDevices #HealthcareInnovation #AIinEurope #EUDelivers #TechRegulation #PatientSafety #DigitalHealth

The US FDA has been exploring how to regulate medical devices that incorporate AI and machine learning (ML) and evaluating the role of AI/ML in medical product development. Cooley LLP's life sciences and healthcare regulatory team has compiled a handbook outlining the key issues for device software manufacturers to consider as they attempt to navigate this complex regulatory area. Check out the handbook with the link below. #CooleyREG #AI

Regulation of AI in healthcare is evolving. The FDA is working to protect public health as AI technology is applied to medical devices. You can learn more here: https://lnkd.in/eYaQT8DU

Compliance Monday’s: FDA to address regulatory challenges for generative AI in MedTech   As AI-driven innovations revolutionize the medical technology landscape, FDA is taking proactive steps to ensure patient safety and tackle regulatory challenges for generative AI while encouraging groundbreaking advancements. #GenerativeAI can revolutionize diagnostics, treatment planning, and medical device development but poses challenges in validation, accountability, and compliance. FDA's evolving guidelines aim to address these complexities, creating a balanced framework that supports innovation without compromising safety.   Compliance Group Inc can provide the expertise needed in validation, risk management, and regulatory compliance to help organizations overcome these challenges effectively.   Stay updated on how these regulatory developments will shape the future of #MedTech. Read More: https://lnkd.in/g7Tk4msD Visit us at https://lnkd.in/gXZQ-cHc  Please send your questions to info@complianceg.com   #compliancemondays #generativeai #medtech #fda #healthcare #validation #patientsafety #complianceg #innovation #ai #regulatory #compliance

📢🏥 Exclusive whitepaper: „The Interaction of Regulatory Affairs, AI and Data Protection in Medical Technology – 20 Questions and Answers“ In addition to the requirements of the MDR (Medical Device Regulation) and data protection, medical technology companies must now also comply with the new provisions of the AI Act. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology? Our Digital Health focus group (Oliver Stöckel, Afra Nickl, Marius Drabiniok and Fabian Bauer) answers 20 key questions in their new white paper and provides exclusive insights into current requirements and future topics in medical technology. 💡 To the whitepaper: https://lnkd.in/dHmsTgtZ #DigitalHealth #Medicaltechnology #Whitepaper #AI #Dataprotection #Innovation

Discover how a global medical device manufacturer slashed manual complaint management by 75% and achieved regulatory compliance with strategic AI integration. This case study, learn about AI's potential to revolutionize complex processes and enhance operational efficiency. Read more: https://bit.ly/3SW93E2 #AI #artificialintelligence #Compliance #OperationalEfficiency #LifeSciences

In case you missed it , listen to the webinar “Shaping Trust in AI: Ensuring Conformity of AI–enabled Medical Devices amid Regulatory Changes (EUAIA)” webinar. The webinar presented a brief overview of gaps regarding specific requirements of AI conformity assessment and discussed the significant impact on the medical devices industry Access the recording and slides, here: https://bit.ly/4bB1tFc #MedicalDevices #ShapingTrustinAI #AI #MDR

Consumers love AI…until they have to trust it.   The FDA just added 191 medical devices to their list of cleared AI/ML medical devices. Is this bad news for #healthcaremarketers? Are we about to face a patient body that knows enough about AI to be afraid, but not enough to be comfortable? Transparency is important in healthcare. Entering a world where patients are routinely checking which AI is being used in their healthcare process is a gamechanger.  Up until now, the AI #healthcaremarketing challenge has largely been to reassure clinicians that their professional skills are not being replaced by a machine. It’s been an uphill battle, but one that has been won on many fronts. Thanks in part to the FDA’s list, patient education might be the next frontier. (Link to FDA AI/ML cleared list in comments)

AI/ML Regulations for medical devices: The FDA, Health Canada, and the UK’s MHRA have outlined 10 guiding principles to promote safe, effective AI/ML medical devices. These guidelines aim to foster Good Machine Learning Practice (GMLP), addressing the complexities and risks of AI in healthcare. Key principles include leveraging multidisciplinary expertise, following robust engineering and security standards, ensuring diverse and representative clinical data, and keeping training and testing datasets independent. The guidelines emphasize real-world performance, user transparency, and regular monitoring to prevent bias and model degradation. Collaboration with organizations like the IMDRF is encouraged for future advancements in GMLP, supporting safe AI/ML innovations in healthcare. Follow Citrusx for more updates

Are you confused about the AI Act and what it means for health tech and medical devices? 🤖 Join us at Labquality Days 2025 for Erik Vollebregt's two lectures and gain clarity and insights on this complex topic! ❄️ Read our interview with Erik in the link below. Navigating the ‘Regulatory Lasagna’: How the EU’s New AI Act Impacts Healthcare and Medical Devices: https://lnkd.in/d75qqNue #LQD2025 #LabqualityDays #MedicalDevices #HealthTech #AI #ArtificialIntelligence #Healthcare #AIinHealthcare