A medical manufacturer had US-approved surgical equipment, but the current design was not working for some international markets.
International markets required the system to be smaller and more compact, but still maintain the necessary functionality. With the new changes, the manufacturer wanted to conduct testing in the US to get FDA approval, which would facilitate approval in international markets.
We tested the redesigned device with a surgical team trained on the current system.
We conducted in-person testing in an outpatient clinic, in the surgical team’s environment. We evaluated system setup, tool programming, and use during a simulated surgery.
We evaluated and updated their risk assessment (uFMEA), aligning with previously submitted documents. We also identified new risks and user paths for the redesigned equipment.