Market success with compliant and usable medical devices
A survey of reported incidents from BfArM has shown that at 42,1 percent of the incidents are based on usability issues of medical devices. 70% of FDA recalls of software products are due to usability problems.
International studies have shown that a lot of incidents with medical devices are caused by incorrect use of the device. Usability gets more and more in the interest of both, public and legislative authorities.
Since the MDD 93/42/EEA has been amended by the usability aspect in March 2010, all manufacturer of medical devices are now obliged to evaluate the usability within the development process and to design their products with a focus on the needs of the intended users.
MedSysCon provides support in implementing the requirements on usability and supports you in developing plans and specifications for the validation of your medical devices.