Combination product human factors engineering programme
Providing human factors (HF) support for our client on a combination product development, from initial analysis to final FDA submission.
Using our initial HF analysis, we developed user-friendly instructions for use (IFU) and product labelling. We then conducted a formative study which helped optimise the IFU further, and developed the protocol for a validation study.
Supported our client’s human factors engineering (HFE) programme to form part of a successful FDA submission.