This on-demand webinar explores the evolving cybersecurity requirements for medical devices under the U.S. FDA’s CDRH and the EU’s MDR and IVDR frameworks. It provides a detailed overview of the FDA’s expectations, including vulnerability monitoring, lifecycle security management, and the inclusion of a machine-readable Software Bill of Materials (SBOM). The session also examines key regulatory documents—such as the 2023 Final Premarket Guidance, 2024 Draft Updates, and the 2016 Postmarket Guidance—offering insights to help manufacturers navigate compliance and proactively address regulatory expectations.
This is the third presentation from day 2 of the live 3-day virtual symposium hosted through the Sotera Academy where Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device. Click here to watch all of the presentations on the Sotera Academy or fill out the form on this page for access.