Why Combination Devices Are More Complex
Adding functions increases more than the number of documents. Whether energy types operate simultaneously, reinforce one another, determine the principal purpose or require separate product versions can change classification and verification plans.
Working Method
- Build a complete function-and-parameter matrix
- Identify the principal mechanism and worst-case combinations
- Determine whether functions should be removed, limited, separated or independently verified
- Align the overall intended purpose, instructions and market claims