Usability and validation fulfilled by a single source

A survey of reported incidents from BfArM concluded that at 42,1 percent of the incidents are based on usability issues of medical devices. Also international studies have shown that a variety of incidents with medical devices are caused by incorrect use of the device. Therefor usability is more and more in the interest of both, public and legislative authorities.
To counteract this issue, the European directive 2007/47/EC amended the essential requirements in Annex I of the MDD 93/42/EEA by the usability. Since March 2010 every manufacturer of medical devices is obliged to evaluate the usability within the development process and to design their products with a focus on the needs of the intended users.
PROSYSTEM AG provides you with the expertise to implement requirements on usability and supports you to develop plans and specifications for the validation of your medical devices.

Please contact us for further details concerning “Usability and validation” or a non-binding offer.