Stakeholder Requirements Analysis
During context analysis, we interview or observe users in their natural usage context and environment. We first define the user groups and then develop interview guidance questions for each user group. This research activity enables the definition of actual user needs, to then derive system requirements. This generates design input and eventually leads to a product that helps its users succeed.
We help you through systematic requirements engineering to:
- Understand actual user needs and stakeholder requirements. This will be your company treasure that you cannot discover by direct inquiry.
- Generate a list of all use scenarios and tasks in their respective context, so that you are aware of the full potential of your medical device.
- Produce a use specification, which describes the exact context of use and is a necessary component of an FDA-compliant usability file.
We are happy to assist you and coordinate the testing effort depending on the approval location (e.g. the US).