Reclassification of Software Automated Medical Devices

🎤  José Mora    |  📅  February 26, 2025    |  🕒  11 AM Eastern Time US

Is Your Software-Driven Medical Device Ready for Reclassification?

Why Wait? Secure Your Spot Today.

🚀 Do you fully understand how software-automated medical devices are classified? 🚀 Are you prepared for reclassification challenges that may impact compliance and approvals? 🚀 Want expert insights on risk-based categorization and regulatory harmonization?  This webinar provides everything you need to stay ahead in the evolving medical device landscape. This webinar is essential for professionals involved in: 👨‍💻 Regulatory & Compliance – Align device classifications with global regulatory expectations 🏭 Manufacturing & Production – Ensure smooth transitions in classification changes 🛠 Quality Assurance & Risk Management – Navigate compliance challenges for software-based devices 📊 Research & Development – Integrate regulatory strategies into product design 🧑‍🔬 Design & Engineering – Optimize device classification for accelerated market entry Applicable industries: Medical Devices | Digital Health | Software as a Medical Device (SaMD) | AI in Healthcare

The regulatory landscape for software-automated medical devices is rapidly evolving, with global authorities like the FDA, EMA, and other regulatory agencies continuously updating classification frameworks. Are you prepared for the impact of reclassification on compliance, approval timelines, and market access?

From AI-powered diagnostics to robotic surgical assistants, software-driven medical devices are transforming healthcare. However, their classification is a critical factor that dictates regulatory requirements, risk assessments, and commercialization strategies. Understanding these regulatory changes is key to avoiding delays, ensuring compliance, and maintaining a competitive edge in the digital health market.

Join José Mora, a renowned consultant with over 30 years of experience in medical device manufacturing and regulatory compliance, as he provides expert guidance on navigating reclassification challenges, aligning with evolving global regulations, and securing seamless market access.

Key Topics Covered:

📌 Introduction to software-automated medical devices and their various types

📌 Regulatory Authorities & Compliance Standards

📌 FDA 21 CFR Part 820, 21 CFR Part 11, EMA MDR 2017/745

📌 Understanding classification frameworks

📌 Challenges in classification, reclassification, and regulatory approval processes

📌 IEC 62304 software lifecycle processes, ISO 13485:2016 (QMS for Medical Devices) and ISO 14971:2019 (Risk Management for Medical Devices)

📌 Compliance requirements and the impact of classification on market access 

📌 International harmonization efforts and their role in regulatory alignment 

📌 Discussion on proposed reclassification frameworks and their implications 

📌 Practical strategies to navigate evolving regulations and ensure compliance