A company has conducted several formative human factors studies and there are still use errors and difficulties associated with the IFU or instructional materials. The instructions have been tested and iterated several times by different people but still the issues persist. What could be going wrong?
Agilis is your trusted human factors partner for the global medical market. We help new and established companies achieve successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. Agilis’ proven human factors strategies, process and expertise drive regulatory success and speed to market – the first time.