confinis

📢 New White Paper Alert! 📢 We’re excited to announce the release of our latest white paper: "AI/ML Medical Devices: Navigating Regulatory Requirements Amidst Evolving Technology Standards". As AI and machine learning continue to revolutionize the medical device sector, understanding and meeting regulatory requirements is more critical than ever. This white paper provides insights into the regulatory frameworks in the EU and US, with actionable strategies for manufacturers. 📥 Download it now on our website and gain practical guidance on navigating complex AI/ML compliance. https://lnkd.in/egsN9nVJ For all your regulatory compliance needs, confinis offers tailored support to ensure your AI and medical device innovations align with the latest standards and guidelines. https://lnkd.in/eTvaSe3J #MedicalDevices #AI #MachineLearning #RegulatoryCompliance #confinis

🌍 We will present with Beat U. Steffen, RAC, FRAPS, founder of Confinis ag on Navigating Regulations for Combination Products: US, EU and China Perspective. ⏰ Time: Thursday, Nov 7, 2024 ,11:00 am-12:00 pm EST 📋 Free registration: https://lnkd.in/eiGsjqXk 🤝 Join us for an insightful webinar where we will explore the key regulations governing combination products across major markets, including China, the EU, and the US. 📍 This session will provide a high-level overview of the primary regulatory frameworks, highlight the differences and similarities between these regions, and delve into the common types of combination devices that are typically cleared. 📍 Additionally, our experts will share valuable insights into the pitfalls to avoid and best practices to follow for successful combination device approvals. 📍 Key regulations of combination products in US, EU and China Differences and similarities between US, EU and China combination products. Common types of combination products cleared and their typical classifications and requirements. 📍 Pitfalls and best practices for combination products approvals.

📢 New White Paper Release: AI in Auto-Injector Technology! 📢 #confinis is excited to introduce our latest white paper, "Exploring Artificial Intelligence in Auto-Injector Applications." This comprehensive review covers how AI integration is transforming auto-injector platforms, from improving patient compliance and experience to navigating complex regulatory landscapes in both the EU and US. Discover the innovative ways AI can enhance the design, safety, and effectiveness of auto-injectors for personalized care. 📥 Download now on our website to stay informed on the latest advancements! https://lnkd.in/e_bCDDjm For tailored support with regulatory needs in auto-injectors and other medical devices, contact confinis to ensure a smooth path to compliance. https://lnkd.in/eTvaSe3J #AutoInjectors #MedicalDevices #AI #PatientCompliance #HealthcareInnovation #RegulatoryCompliance

🔍 Million dollar question: where should you launch a new medical device or combination product first, in the EU or in the US? What are the current challenges in both areas? 🤔 If you wondered abou that, come meet us at the Swiss National Regulatory Conference, and let's discuss the best approach together. confinis will be engaging with peers and industry experts on the key regulatory challenges facing Europe today as part of Swiss Medtech. 🌍🩺 We’re excited to share insights and help you navigate these complex times. #innovators #regulatory #compliance #andbeyond #SwissRegulatoryConference #MedTech #RegulatoryStrategy #EUvsFDA

🚨 New White Paper: QMSR and FDA QSR & ISO 13485 Harmonization 🚨 confinis has released a detailed white paper covering the FDA’s Quality Management System Regulation (QMSR) and its alignment with ISO 13485:2016. As medical device manufacturers face key regulatory changes, the deadline for compliance is February 2026. 📥 Download the white paper on our website to stay ahead of these changes and ensure your compliance strategy is robust. https://lnkd.in/dGbatJmJ Our team at confinis is ready to help your organization navigate these regulatory updates with expert guidance. https://lnkd.in/eTvaSe3J #MedicalDevices #QMSR #ISO13485 #FDA #RegulatoryCompliance #confinis

✨ On October 8th, Alfred Lerch from confinis attended the Triangle Biotech Tuesday in Durham, NC. This fantastic event connected professionals from the biotech, life sciences, and pharma industries for collaboration and networking. At #confinis, we’re committed to helping medical device manufacturers, pharmas, and biotechs navigate the intricacies of #RegulatoryCompliance and #QualityManagement. 🧑⚕️💡 If you need expert support, reach out to confinis to ensure your success in this ever-evolving landscape!  https://lnkd.in/eTvaSe3J #Biotech #RegulatoryCompliance #MedicalDevices #Pharma #TriangleBiotech #confinis

📢 Exciting News! 📢 We’re thrilled to announce that Daniel M., from confinis, will be a key speaker in an upcoming online course on Design Controls for Drug-Device Combination Products organized by ECA Academy. 🧑⚕️💡 This course dives deep into critical regulatory requirements and practical insights for combination products. If you're working in the medical device or pharma sector, you won't want to miss this opportunity! 📅 When: October 15-16, 2024   🔗 Learn more: https://lnkd.in/ekvwPbcV #MedicalDevices #DrugDeviceCombination #RegulatoryCompliance #andbeyond #ECAAcademy #confinis #CombinationProducts #article117

🚀 New White Paper: Regulatory Compliance for AI-Enabled Medical Devices 🚀 confinis is proud to release AI-Enabled Medical Devices: A Comprehensive Regulatory Review, a white paper that delves deep into the evolving regulatory landscape for AI-driven medical devices. As AI continues to revolutionize healthcare, regulatory compliance becomes a critical concern. The white paper covers key sections, including: 1️⃣ AI and EU Regulations: A detailed overview of the European AI Act, liability frameworks, and the risk-based approach in regulating AI systems for medical devices.   2️⃣ FDA and AI: Insights into the FDA’s guidelines on Software as a Medical Device (SaMD), focusing on AI/ML-enabled devices and Good Machine Learning Practices (GMLP). 📥 Download the white paper now and discover how confinis can support your AI device's regulatory compliance journey. https://lnkd.in/e2ndj484 #AIMedicalDevices #RegulatoryCompliance #HealthcareInnovation #AI #MedicalDevices #confinis

Clarification guidance on which products fall into the scope of Regulation 2017/746 and qualifies as an in vitro diagnostic medical device (IVD) or an accessory to an IVD #ivd, #medtech, #euivdr, #eumdr, #medicaldevice, #medicaldevices, #surveillance, #regulatoryintelligence, #ivdr, #mdr, #confinis

🚀 New White Paper: Regulatory Compliance for AI-Enabled Medical Devices 🚀 confinis is proud to release AI-Enabled Medical Devices: A Comprehensive Regulatory Review, a white paper that delves deep into the evolving regulatory landscape for AI-driven medical devices. As AI continues to revolutionize healthcare, regulatory compliance becomes a critical concern. The white paper covers key sections, including: 1️⃣ AI and EU Regulations: A detailed overview of the European AI Act, liability frameworks, and the risk-based approach in regulating AI systems for medical devices.   2️⃣ FDA and AI: Insights into the FDA’s guidelines on Software as a Medical Device (SaMD), focusing on AI/ML-enabled devices and Good Machine Learning Practices (GMLP). 📥 Download the white paper now and discover how confinis can support your AI device's regulatory compliance journey. https://lnkd.in/e2ndj484 #AIMedicalDevices #RegulatoryCompliance #HealthcareInnovation #AI #MedicalDevices #confinis