The design and development of your software device must be properly documented, according to its intended use. Proper documentation is critical to the success of any submission or regulatory inspection related to the device.
 
 
GEMAR specialists follow the industry standard V-model in helping clients to prepare the validation file:

 

Each phase is verified, to confirm with formal testing that the output of the phase meets its requirements.
 
 
In addition, software validation is documented in order to produce evidence that the software conforms with the user needs and intended uses of the device with checking for proper operation of the software in its actual or simulated use environment.
 
 
Software validation can be very expensive if not managed in the right way, and GEMAR's expertise will bring you into compliance in the most cost effective way possible, following the path of least resistance.