Summary
A discussion about User Requirements in a medical device.
User Requirements
User Requirements are usually specified before designing and implementing the system. They provide a set of constraints from a User's perspective. Examples:
- The system shall weigh no more than 2kg
- The system shall operate on battery for at least 8 hours
- The system shall be compliant with common practices used in a majority of hospitals in the USA and Europe
- All User Interface instructions shall use a maximum of Grade 8 level language
User Requirements are verified using a different type of test methodology and will not be covered here.