Monolithic application and medical devices

[p_dust]

Hi all

We have a monolithic medical application with parts which are considered medical devices and other parts not.
The initial idea is to remove from the monolith all the medical device code and place it into a new Java library (i.e. libmeddev-oncology.jar) with its own documentation and lifecycle. The library will consist only of Java classes without user interface, just the algorithms.

Will this new library be acceptable as a medical device from a regulatory perspective, even if this library cannot run on its own (always requiring an application as runtime host)?

 

[Enternationalist]

This sounds like a particular question for people over on the 62304 forums who are more familiar with software, and dependent on local regulations. I don't think ISO 13485 really can or should tell you if your software is a medical device or not.

 

[yodon]

Will this new library be acceptable as a medical device from a regulatory perspective, even if this library cannot run on its own (always requiring an application as runtime host)?

No, it must first meet the definition of a medical device. Read through the SaMD Key Definitions document for details.