Hi all!
Let's suppose that I want to build a software library whose main aim is to transfer data from a medical device to a mobile phone app.
The library will be embedded into the app.
Does the library become a Software as Medical Device (SaMD) even if its only aim is to move data from the medical device to the smartphone app?
Thank you in advance.
Let's suppose that I want to build a software library whose main aim is to transfer data from a medical device to a mobile phone app.
The library will be embedded into the app.
Does the library become a Software as Medical Device (SaMD) even if its only aim is to move data from the medical device to the smartphone app?
Thank you in advance.