confinis

confinis wishes you all a great holiday season! From the 24th of December, our team will be taking a short break to recharge and prepare for an exciting 2025. We'll be back and ready to support you starting Monday, January 2nd, 2025. In the meantime, take this opportunity to explore what’s new at confinis: 🌟 Exciting News! We’ve just launched the confinis academy, a powerful platform designed to help you stay ahead in the ever-evolving regulatory landscape. Check out our online courses and learn more here: https://lnkd.in/eCJpzXxA 🤖 Discover the Future with AI: Our tailored AI configurations are transforming regulatory processes, making compliance more efficient than ever. Contact us to learn how we can support your business with innovative AI solutions. 🎉 Here's to a joyful holiday season and an incredible start to 2025! Warm regards to all of you! #confinis #regulatory #compiance #andbeyond #innovators

🚨 Exciting News from Confinis! 🚨 We’re thrilled to announce the launch of our latest online course: Transitioning to FDA’s Quality Management System Regulation (QMSR)! 🎉 This course is designed to help regulatory professionals, quality managers, and medical device manufacturers navigate the FDA’s transition to QMSR with confidence. 🌟 What you’ll learn: ✔️ Key changes under QMSR and ISO 13485 alignment ✔️ Risk-based quality management practices ✔️ Strategies for gap analysis, documentation updates, and audit preparation ✔️ Streamlined compliance processes for global market access 💡 Whether you're new to regulatory compliance or looking to strengthen your expertise, this course equips you with the tools to succeed in today’s evolving regulatory landscape. Special Launch Offer: To celebrate, we’re offering 25% off for a limited time! Use code: QMSR25 at checkout to claim your discount. 👉 Enroll now and lead your organization confidently through the QMSR transition! https://lnkd.in/dGRGa_fJ 👉 confinis is here to help you with your medical device regulatory compliance https://lnkd.in/d4UFHdkx #QMSR #ISO13485 #RegulatoryCompliance #MedicalDevices #QualityManagement #ConfinisAcademy #Training

🎓 Master EUDAMED, Swissdamed, and UK Registration with confinis Academy! 🎓 Navigating the complexities of medical device registration across the EU, Switzerland, and the UK can be daunting. #confinisAcademy ’s course on "EUDAMED, Swissdamed, and UK Registration" provides the clarity and expertise you need to succeed in these critical regulatory markets. 💻 What You’ll Learn: - The essentials of EUDAMED compliance for the EU market - Key steps for Swissdamed registration in Switzerland - Insights into the UK medical device registration process - Strategies to streamline registration and avoid common pitfalls 🌟 Why Choose confinis Academy? 🌟 - Gain practical knowledge tailored for medical device professionals - Unlock special rates on confinis consulting services upon course completion 🎉 Limited-Time Offer: Enjoy a 25% discount on your first course with our exclusive launch code! 📥 Enroll today to ensure your device is market-ready: https://lnkd.in/dsh_4rCx #confinis is your trusted partner for navigating the complexities of medical device regulatory compliance with confidence and expertise. https://lnkd.in/eTvaSe3J #confinisAcademy #MedicalDevices #EUDAMED #Swissdamed #UKRegistration #RegulatoryCompliance #MedicalDeviceRegistration

📢 New White Paper Alert! 📢 confinis is excited to announce the release of our latest white paper: "Aligning ISO 13485 with MDR: Ensuring Compliance and Quality in the Medical Device Supply Chain." This comprehensive guide explores how ISO 13485 and MDR (EU) 2017/745 work together to streamline compliance, improve quality management, and address key challenges in the medical device supply chain. 📥 Download the white paper on our website to learn: 🌟 Best practices for harmonizing ISO 13485 with MDR requirements 🌟 Strategies for managing supplier and distributor compliance 🌟 Practical insights into post-market surveillance and risk management Download it here: https://lnkd.in/ehzKu4zP Whether you’re enhancing your QMS or tackling compliance challenges, confinis is here to help. Our expert team offers tailored support for all your medical device regulatory and compliance needs. 🌟 Get in touch today to ensure your success in navigating complex regulatory landscapes! https://lnkd.in/eTvaSe3J #MedicalDevices #ISO13485 #MDR #RegulatoryCompliance #SupplyChain #QualityManagement #confinis

🎓 Master ISO 13485 Compliance with confinis Academy! 🎓 Are you a startup navigating the complexities of ISO 13485 compliance? Look no further! confinis Academy’s newly launched course, "ISO 13485 Compliance for Startups", is here to guide you through the essentials of Quality Management Systems for medical devices. 💻 What You'll Learn: - The fundamentals of ISO 13485 - Best practices for establishing a Quality Management System (QMS) - Strategies to ensure compliance from the ground up 🌟 Why Choose confinis Academy? 🌟 - Gain practical insights tailored for startups - Unlock special rates on confinis consulting services and QMS implementation upon course completion 🎉 Launch Offer: Get 25% off for a limited time with our exclusive discount codes! 📥 Enroll today and take the first step toward ISO 13485 compliance: https://lnkd.in/e84gi2fv https://www.confinis.com #confinisAcademy #ISO13485 #MedicalDevices #QMS #StartupSupport #RegulatoryCompliance #confinis

🎓 Introducing confinis Academy: Your Online Platform for Regulatory and Compliance Learning! 🎓 We are thrilled to announce the launch of confinis Academy, a comprehensive e-learning platform tailored for the medical device industry. Designed to empower professionals and startups, our courses provide deep insights into regulatory and compliance challenges while preparing you for success in an ever-evolving industry. 🌟 Exclusive Launch Offer: 🌟 For a limited time, enjoy 25% off your first course with our special launch discount code! Plus, completion of our courses unlocks discounts and preferred rates on confinis services. 💻 Our First Courses Include: 1️⃣ ISO 13485 Compliance for Startups 2️⃣ EUDAMED, Swissdamed, and UK Registration 3️⃣ Challenges of AI Integration in Medical Devices 4️⃣ Cybersecurity Challenges for Medical Devices 5️⃣ IEC 62304 Software Development (available as a bundle with AI and Cybersecurity) Don’t miss this opportunity to enhance your knowledge and stay ahead in regulatory compliance! 📥 Learn more and enroll today: https://lnkd.in/eCJpzXxA #confinisAcademy #Elearning #MedicalDevices #RegulatoryCompliance #ISO13485 #Cybersecurity #AI #EUDAMED #IEC62304 #Swissdamed

🌍✨ Excited to see the International Regulatory Pathway Project, an impactful initiative organized by the Digital Medicine Society (DiMe), finally come to life, and honored for the opportunity to contribute to it! This project is a significant step forward in understanding regulatory and market access pathways for digital health technologies worldwide. DiME worked alongside global experts to provide clarity and actionable insights for innovators in the digital health space. Yesterday, the project's outcomes were presented during a public webinar, showcasing important progress and advocating toward harmonizing regulatory and implementation approaches and fostering innovation in digital health. The resources available include country-specific guides, step-by-step flowcharts, and real-world case studies. Learn more about the project and make good use of the resources available here: https://lnkd.in/eTGPQW23 Thank you to the amazing team at Digital Medicine Society (DiMe) (Special mention for Megan Coder's always amazing leadership), all the partners, and everyone else involved for driving this forward. I'm proud of the small part I played in such a meaningful initiative and am excited to see its impact on the future of digital medicine. And thank you, confinis, for encouraging contributing to these initiatives. #DigitalHealth #RegulatoryPathways #Evidence #EvidenceGeneration #GotoMarket #Innovation #Collaboration #DiME

Revised MDCG 2023-3 Guidance Document, why does it matter? 🌐 New MDCG 2023-3 Rev.1 Guidance Released in November 2024: Strengthening Vigilance for Medical Devices and IVDs under MDR and IVDR In November 2024, the MDCG released its updated guidance, MDCG 2023-3 Rev.1, a critical document for the medical device and diagnostics industries. This update refines vigilance practices under the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), making it a key resource for manufacturers. Here’s why it matters: 🔍 Clarity & Consistency: Unified definitions for vigilance terms across MDR and IVDR reduce ambiguities, ensuring accurate incident reporting. 💡 Enhanced Patient Safety: Clear guidelines for identifying and reporting serious incidents promote timely responses to risks impacting patient health. ⚙️ Improved Compliance: Updated definitions, timelines, and criteria support better compliance management, helping manufacturers meet obligations effectively. 🧬 IVD-Specific Considerations: Tailored examples for in vitro diagnostics address unique challenges like diagnostic errors and indirect patient harm. 🌍 Public Health Preparedness: New guidance on serious public health threats, such as device-related outbreaks or major product failures, supports proactive risk mitigation. 📊 Streamlined Reporting with Eudamed: Detailed instructions for Eudamed use facilitate efficient, transparent vigilance reporting across the EU. This release is a significant milestone for patient safety and regulatory alignment, helping our industry meet evolving standards. #MedicalDevices #IVDR #MDR #Vigilance #PatientSafety #HealthcareRegulation #Compliance #Eudamed

📢 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.