> how many medical devices are thrown out simply due to issues with the companion software If in the US, did y'all get FDA certification for the internally dev

> how many medical devices are thrown out simply due to issues with the companion software If in the US, did y'all get FDA certification for the internally developed software? Did the vendor? https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products https://www.fda.gov/medical-devices/device-advice-comprehens...