R
rumplefish
Hi guys,
I'm writing the software architecture and detailed design documents for a class c medical device.
I have two questions:
1. In the architecture document, it says I need to identify segregation needed for risk control. Is that only for cases when some of the software components are not Class C?
2. In the detailed design, one of the component is the software logic, i.e the algorithm. What's the level of detail I need to go to? Do I need to write down the code, all the rules the algorithm, or is a general description of the workflow, the inputs and outputs is enough?
The company I'm doing this is pretty reluctant on publishing the entire algorithm....
Thanks!
I'm writing the software architecture and detailed design documents for a class c medical device.
I have two questions:
1. In the architecture document, it says I need to identify segregation needed for risk control. Is that only for cases when some of the software components are not Class C?
2. In the detailed design, one of the component is the software logic, i.e the algorithm. What's the level of detail I need to go to? Do I need to write down the code, all the rules the algorithm, or is a general description of the workflow, the inputs and outputs is enough?
The company I'm doing this is pretty reluctant on publishing the entire algorithm....
Thanks!