Cloud Connected Medical Device

DanBOS

Registered
We are developing a medical device with:

A. On-device software (incl. touchscreen controls), as well as,
B. Cloud software that allows certain device operations to be performed remotely.

The device will be built by a contract manufacturer, who will also load the on-device software. We will be responsible for - 1) developing and deploying the cloud software, and, 2) Providing updates to the on-device software (OTA or providing customers with USB sticks).

My question is --> Do we register as a specification developer or a manufacturer with the FDA?.
 

mihzago

Trusted Information Resource
Just to add, when you do Establishment Registration and Product Listing, you can list one product as a manufacturer and the other as a specification developer.
 
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