Validation (Summative) Testing
We will conduct a high-fidelity validation test with end users, in accordance with the FDA human factors guidance. The purpose of this evaluation will be to demonstrate that users can perform critical tasks while using the product in a safe and effective manner.
We will recreate hospital wards, living rooms or other high-fidelity use environments in our usability labs to allow representative users to carry out tasks while using the product in a realistic setting. The test will also evaluate the labelling and any associated instructional material. To add to the high fidelity of the simulation, actors will play the role of nurses, family members or patients and interact with participants in a realistic manner. Human Factors Specialists will monitor the test proceedings and document any use errors, close calls, use difficulties, and instances necessitating assistance.
We will synthesize findings from the validation test in a suitable report. If desired, we will also participate in any meetings between you and the FDA Human Factors Reviewers that are related to your 510(k) or PMA submission.