There have been significant changes in both the US and global regulatory environments affecting human factors for medical devices and combination products. While done with good intent, many of these changes have added complexity and, in some cases, confusion about how to ensure a successful human factors submission.
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.