Factory has experience in the preparation and execution of different medical device trial
designs including 'phase I-IV' clinical trials, safety & performance studies, efficacy studies, effectiveness studies,
clinical economic studies, quality of life studies, and post-marketing studies. Factory has also experience with different
device classes like Class II (a and b) and Class III devices.
We have performed multi-centre clinical trials with 20 to 300 patients per study, recruited by 2 to 40 participating
investigators in up to 20 different European countries. Follow up periods for clinical device trials vary from one month to two years depending on the calculated safety risks of the device.
We are experienced in evaluating devices in a number of different surgery disciplines, which you can find listed below.
