Mini-Business Case Stage

Stage developed to evaluate low risk projects that include simple revisions or cost saving projects.

Inductive Reasoning
Inductive reasoning makes broad generalizations from specific observations (bottom-up). The investigator collects observations, finds patterns…
Deductive Reasoning
Deductive reasoning is based on the logic that if something is true for a class…
21 CFR 820
The regulations in the United States for the Quality System Regulations for Medical Devices.…
White Space
White space is that unexplored and undiscovered domain of opportunity for new products and new…
Voice of the Customer
VOC is a process for gathering and prioritizing needs from customers. It uses indirect questioning…
Verification & Validation
Generally used for testing a design or process to ensure it meets requirements.
Use Case
A written description of how users will perform tasks using the product. It outlines, from…
Traceability Matrix
Tool used to link customer requirements to design inputs/ product requirements to design outputs and…
Technology Strategy
Defines the set of technologies required by the firm to support the product strategy, the…
Strategy Canvas
The Strategy Canvas is a tool for mapping out white space in strategies. It was…