Medical devices can present unique challenges for manufacturers. Consequences for malfunctioning equipment can be dire. Because of this, medical device manufacturers must work hard to ensure that their products never fail.
“Medical devices are unique in the scrutiny to which their quality is measured and guaranteed,” says Landon Goldfarb, senior applications engineer, Instron. Because medical devices are regulated by the FDA, “both the amount of testing and the verification of results is held to a higher standard than other products,” he says.