Dive into the latest blog by Yervant Chijian, Director/Team Lead for Medical Devices/IVD Australia, on the key steps to harmonize Medical Device Software Machine Learning best practices. Yervant expertly breaks down the IMDRF's newly published draft guideline, which includes 10 guiding principles essential for medical device software manufacturers. Main Takeaways: ✔️ Embrace a Total Product Life Cycle (TPLC) approach. ✔️ Establish rigorous AI management processes early and maintain them. ✔️ Ensure clinical study datasets represent the intended patient population. ✔️ Monitor deployed models and manage re-training risks. ✔️ Learn how these principles can streamline your software development and post-market processes, ensuring your AI/ML algorithms maintain high standards in clinical practice. Full article here: https://lnkd.in/gJMFW6ng #MedicalDevices #MachineLearning #AI #HealthcareInnovation #RegulatoryCompliance #PharmaLex #IMDRF #TPLC #PharmaLex
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Dive into the latest blog by Yervant Chijian, Director/Team Lead for Medical Devices/IVD Australia, on the key steps to harmonize Medical Device Software Machine Learning best practices. Yervant expertly breaks down the IMDRF's newly published draft guideline, which includes 10 guiding principles essential for medical device software manufacturers. Main Takeaways: ✔️ Embrace a Total Product Life Cycle (TPLC) approach. ✔️ Establish rigorous AI management processes early and maintain them. ✔️ Ensure clinical study datasets represent the intended patient population. ✔️ Monitor deployed models and manage re-training risks. ✔️ Learn how these principles can streamline your software development and post-market processes, ensuring your AI/ML algorithms maintain high standards in clinical practice. Full article here: https://lnkd.in/eH7HaNaX #MedicalDevices #MachineLearning #AI #HealthcareInnovation #RegulatoryCompliance #PharmaLex #IMDRF #TPLC #PharmaLex
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Along with Cybersecurity, Functional Safety is one of the hottest topics impacting the certification of smart products in both medical and non-medical verticals. What questions do you have about how Functional Safety impacts your products?
In the U.S., Canada, Europe and elsewhere, regulatory bodies are developing new requirements to ensure the safety, quality and performance of AI-driven healthcare solutions. It’s crucial for medical device manufacturers to successfully navigate these regulations to bring innovative products to market. Download our new AI-Powered Innovation in Healthcare fact sheet to learn more about the evolving regulatory landscape and how to effectively bring AI-enabled and machine learning medical devices to market. Link in comments. #AI #machinelearning #medicaldevice #healthcare
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Dive into the latest blog by Yervant Chijian, Director/Team Lead for Medical Devices/IVD Australia, on the key steps to harmonize Medical Device Software Machine Learning best practices. Yervant expertly breaks down the IMDRF's newly published draft guideline, which includes 10 guiding principles essential for medical device software manufacturers. Main Takeaways: ✔️ Embrace a Total Product Life Cycle (TPLC) approach. ✔️ Establish rigorous AI management processes early and maintain them. ✔️ Ensure clinical study datasets represent the intended patient population. ✔️ Monitor deployed models and manage re-training risks. ✔️ Learn how these principles can streamline your software development and post-market processes, ensuring your AI/ML algorithms maintain high standards in clinical practice. Full article here: https://lnkd.in/gJMFW6ng #MedicalDevices #MachineLearning #AI #HealthcareInnovation #RegulatoryCompliance #PharmaLex #IMDRF #TPLC #PharmaLex
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Dive into the latest blog by Yervant Chijian, Director/Team Lead for Medical Devices/IVD Australia, on the key steps to harmonize Medical Device Software Machine Learning best practices. Yervant expertly breaks down the IMDRF's newly published draft guideline, which includes 10 guiding principles essential for medical device software manufacturers. Main Takeaways: ✔️ Embrace a Total Product Life Cycle (TPLC) approach. ✔️ Establish rigorous AI management processes early and maintain them. ✔️ Ensure clinical study datasets represent the intended patient population. ✔️ Monitor deployed models and manage re-training risks. ✔️ Learn how these principles can streamline your software development and post-market processes, ensuring your AI/ML algorithms maintain high standards in clinical practice. Full article here: https://lnkd.in/d2sdY9WG #MedicalDevices #MachineLearning #AI #HealthcareInnovation #RegulatoryCompliance #PharmaLex #IMDRF #TPLC #PharmaLex
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In the U.S., Canada, Europe and elsewhere, regulatory bodies are developing new requirements to ensure the safety, quality and performance of AI-driven healthcare solutions. It’s crucial for medical device manufacturers to successfully navigate these regulations to bring innovative products to market. Download our new AI-Powered Innovation in Healthcare fact sheet to learn more about the evolving regulatory landscape and how to effectively bring AI-enabled and machine learning medical devices to market. Link in comments. #AI #machinelearning #medicaldevice #healthcare
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The FDA, along with U.K. and Canadian regulators, has unveiled new guidelines for machine learning-enabled medical devices. 🏥 These principles focus on enhancing transparency and standardizing critical information to ensure patient safety and better clinical outcomes. Curious about the future of AI in medical devices? Dive into our latest blog post for all the details! 🌐🔍 Link to the Blog: https://lnkd.in/gqTgWFE2 #AI #Healthcare #MedicalDevices #Transparency #PatientSafety #ClinicalOutcomes #Innovation #TechRegulations Sigrid Uhlemann Heinrich von Mettenheim Michael Bothe Szymon Kurdyn Claire Dyson Stefan Hofmann Gianluca Nasi
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🚨 You're Invited! 🚨 Join us for an presentation by Tracey Duffy, First Assistant Secretary of the Medical Devices & Product Quality Division at the Therapeutic Goods Administration. Register here. https://lnkd.in/gbMBDBz3 🗓 Topic: Regulatory Requirements for Software, AI, and Medical Devices Ms. Duffy will provide insights into: - Current regulatory requirements for AI and software in therapeutic applications. - Implementation updates and lessons learned from changes introduced in early 2021. Key takeaways from the whole-of-economy AI Review and its impact on the industry. As a leader at the TGA, Ms. Duffy's expertise will shed light on how cutting-edge technologies are being regulated to ensure safety and efficacy in healthcare. 📅 Don’t miss out—mark your calendars! #MedTech #ArtificialIntelligence #HealthcareInnovation #Regulation #MedicalDevices #Networking
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🔍💡 Optimize Electronic Medical Records with MEDAI 💡🔍 At MEDAI, we are committed to improving the quality and understanding of electronic medical records through our expertise in #medical_text_labeling. 💊 Our approach is to #identify, #categorize and #label relevant medical terms according to your recommendations, thus #providing #accurate and #complete documentation for #health professionals. ✅ #Labeling_medical_texts helps improve the quality of electronic medical records by adding meaningful annotations for better understanding. By #identifying and #categorizing relevant medical terms, we make it easier to find and analyze medical information, resulting in more informed clinical decision-making. 🏥 Entrust your medical text labeling needs to MEDAI and benefit from cutting-edge expertise to optimize your electronic medical records. Together, we can improve the efficiency of health care and the quality of medical decisions. #Medicaltextlabelling #MedicalAnnotation #MedicalInnovation #MachineLearning #DataAnnotation #MedicalExpertise #AI #Annotation
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The convergence of healthcare and technology has ushered in a groundbreaking era of innovation, with Software as a Medical Device (SaMD) leading the charge. From AI-driven diagnostics and real-time monitoring to personalized treatment plans and remote patient management, SaMD is revolutionizing how we diagnose, treat, and care for patients. But with great innovation comes great responsibility. SaMD developers must navigate a complex regulatory landscape, ensure data privacy, and achieve interoperability to unlock its full potential. Explore how SaMD is reshaping modern medicine, the regulatory challenges it faces, and what the future holds in this exciting space: https://lnkd.in/ggfZWQ9X Reach out to DDReg for more support on navigating the regulatory framework for software and AI medical devices. 📧 info@ddregpharma.com 🌐 www.ddregpharma.com #SaMD #HealthcareInnovation #AIinHealthcare #MedTech #RegulatoryCompliance #PatientCare
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