Consultants specialising in regulatory affairs



Human Factor Study and Performance Testing


Human Factor Study for Label Comprehension and Usability is becoming a more common requirement in 510ks. The home user of medical devices or in vitro diagnostics devices that may be prescribed by the physician or purchased over the counter are now part of the final validation of your device's use and user instruction. The FDA is also requiring user verification of instructions in the hospital setting or physician setting for certain classifications of devices.

Our Human factor Studies have included OTC monitoring devices and in vitro diagnostic devices, such as blood glucose devices, spirometers, massagers, cardiac monitors, low level lasers,besides performance testing for hospital use devices, such as safety syringes, safety catheters, sharps containers and safety blood collection devices.

We can write the Human Factor Study Protocol, recruit volunteers in the appropriate device use environment, such as, hospital, surgical suite, home, emergency use, public use, etc. and various target age groups. i.e., 0-2 years infant, 3-12 years child, 13-21 years adolescent, 22 years and older adult. Smith Associates can conduct your Human Factor Study quickly and economically.

The following is FDA's definition of the Simulated Use Testing:

"Simulated use testing (also called usability testing and, occasionally, user testing) involves systematic collection of data from users (participants) using a device (or device component or system) in realistic situations. Data are obtained in a variety of ways, including subjective user feedback, manual and automated measures of user performance, and direct observation."

We will quote a flat fee for performing these safety and Human Factor Studies.