Medical device end user and in use testing can increase customer satisfaction and reduce the risk of costly recalls. This type of testing is an important part of the design validation process required by both ISO 9001 and the new FDA Quality System regulation. During user and use testing, typical users try out prototype devices, packaging and documentation in the environment in which the final products are to be used. User and use testing can identify user interface problems, unanticipated environmental interactions, potential reliability problems and many other product deficiencies. Problems identified during user and use testing can be designed out of products before they are submitted for approval and marketed.
My colleagues and I can coordinate your end user and in use testing programs. We can recruit representative users from the population you expect to use your device. We can arrange the physical facilities needed for the testing. We can conduct the testing and provide you with formal reports on the results.
MSOE's nursing, perfusion and biomedical engineering programs provide a wide range of resources for medical device user and use testing. Our Biomedical Engineering Laboratory is equipped with a variety of medical devices, patient simulators, electrical test equipment and personal computers. Our Governor Warren P. Knowles Nursing Laboratories includes an eight bed basic care unit, a four bed critical care unit and a home care laboratory. Each bed in the basic care unit is equipped with medical air, vacuum and electrical utilities and manual clinical monitoring equipment. Each bed in the critical care unit is equipped with a patient monitor and telemetry system and IV infusion pumps in addition to the standard medical utilities. The unit also has a infant incubator, a ventilator and a defibrillator. These two units provide physical and electromagnetic environments essentially identical to corresponding areas of actual hospitals. Our Perfusion laboratory is housed at St. Luke's Medical Center and has a wide variety of blood pumps, oxygenators and perfusion related monitoring equipment.