In 5.6 "Establish a User Interface Specification"
...
The USER INTERFACE SPECIFICATION shall include:
– testable technical requirements relevant to the USER INTERFACE, including the requirements
for those parts of the USER INTERFACE associated with the selected RISK CONTROL
measures;
NOTE Technical requirements for the USER INTERFACE can include display colour, character size, or placement of
the controls.
– an indication as to whether ACCOMPANYING DOCUMENTATION is required; and
– an indication as to whether MEDICAL DEVICE-specific training is required.
The USER INTERFACE SPECIFICATION shall be stored in the USABILITY ENGINEERING FILE. The USER
INTERFACE SPECIFICATION may be integrated into other specifications.
...
What does this typically mean in practice, do you need to produce a full diagrammed spec as a separate document for the UI like a wireframe sketch showing all buttons and windows and what each one does etc?
I am working with a customer who has an out on the market ivdd with an ivdr update coming, so the prospect of doing this in retrospect is not very appealing
It might be (but so far I've not found it) that they have some wireframes somewhere in DevOps and various tests and other stuff scattered about in DevOps but (I suspect) no formal documentation that I would recognize as a UI specification, I am also not finding risk controls in the current risk analysis related to the UI.
...
The USER INTERFACE SPECIFICATION shall include:
– testable technical requirements relevant to the USER INTERFACE, including the requirements
for those parts of the USER INTERFACE associated with the selected RISK CONTROL
measures;
NOTE Technical requirements for the USER INTERFACE can include display colour, character size, or placement of
the controls.
– an indication as to whether ACCOMPANYING DOCUMENTATION is required; and
– an indication as to whether MEDICAL DEVICE-specific training is required.
The USER INTERFACE SPECIFICATION shall be stored in the USABILITY ENGINEERING FILE. The USER
INTERFACE SPECIFICATION may be integrated into other specifications.
...
What does this typically mean in practice, do you need to produce a full diagrammed spec as a separate document for the UI like a wireframe sketch showing all buttons and windows and what each one does etc?
I am working with a customer who has an out on the market ivdd with an ivdr update coming, so the prospect of doing this in retrospect is not very appealing
It might be (but so far I've not found it) that they have some wireframes somewhere in DevOps and various tests and other stuff scattered about in DevOps but (I suspect) no formal documentation that I would recognize as a UI specification, I am also not finding risk controls in the current risk analysis related to the UI.
