So you think you’ve got a connected medical device?
Medical Device Regulators do not approve good ideas, they approve fully developed medical devices. This means that a working prototype and some testing is not enough. You should not go to a test facility and ask them what testing should be done. You should have planned, documented, and developed the device knowing what testing would be required. All medical devices need to have a complete, current, and accurate design and development file, connected devices especially so. With multiple subsystems, components, software and interconnectivity to consider, following the design control methodology will help the development team stay organized and on track. We are here to help.
This is the first presentation from day 1 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.
