Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass FDA approval with 100% certainty. Put medical devices on the market that are so user-friendly that you are revolutionizing your market!
Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass FDA approval with 100% certainty. Put medical devices on the market that are so user-friendly that you are revolutionizing your market!
We help you create a IEC 62366-1 and FDA-compliant usability file without having to go through complicated regulations and conduct complex usability studies. In this way, you can achieve approval quickly and cost-effectively, even with the requirements of the FDA.
We guide you through the complete development and approval process. We help you to create a lean, FDA and IEC 62366 compliant documentation (Usability Engineering File).
Unfortunately, we observe the following problems again and again:
Don't let it get that far and contact us right away. Together we will develop your human factors engineering process with which you can quickly and cost-effectively obtain a usability file with which you can safely pass the audit and approval.