Curious what different companies consider the final medical device for SaMD.
For medical software that runs in a client-server environment there is a client executable that runs in Windows and is given to the customer as the executable. The server software is a set of .war files (java executables). These executable files are designed and tested to run against recommended (free) server OS-level software that are defined in the manual (like Apache Tomcat).
As a convenience for install, Customer support creates a server image file with the medical device .war files and the free server software. Just installing the free supporting software would not allow the device to run and while recommended, that free software is not the only OS-level software that could run the .war files. The free software recommended and put into the server image file is not modified in any way from it's released version by those manufacturers.
Customer Support performs the installation and configuration which may or may not include set up of the free OS-level software that was not created or modified. Customers may have a server with all the software (except for the .war files) already.
Which would be considered the actual medical device on the server side (or is there another scenario):
1. the .war files that contain the things we designed and released for use with the client
2. the server image with the .war files and the free software OS-level files
Is there a guidance document from any source on this?
Thank you
For medical software that runs in a client-server environment there is a client executable that runs in Windows and is given to the customer as the executable. The server software is a set of .war files (java executables). These executable files are designed and tested to run against recommended (free) server OS-level software that are defined in the manual (like Apache Tomcat).
As a convenience for install, Customer support creates a server image file with the medical device .war files and the free server software. Just installing the free supporting software would not allow the device to run and while recommended, that free software is not the only OS-level software that could run the .war files. The free software recommended and put into the server image file is not modified in any way from it's released version by those manufacturers.
Customer Support performs the installation and configuration which may or may not include set up of the free OS-level software that was not created or modified. Customers may have a server with all the software (except for the .war files) already.
Which would be considered the actual medical device on the server side (or is there another scenario):
1. the .war files that contain the things we designed and released for use with the client
2. the server image with the .war files and the free software OS-level files
Is there a guidance document from any source on this?
Thank you