We Handle the ‘Not So Fun’ Stuff Too
Most devices these days are highly regulated, particularly those in the medical field. So let our human factors consulting team take many of these tedious and time-consuming compliance tasks off your plate. This ensures your involvement in the approval process is as simple, streamlined, and straightforward as possible.
Our HFE core competencies include:
- Submitting HFE files to the FDA
- Supporting risk management
- Conducting formative and summative studies
- Ensuring HE75 and IEC62366 compliance
- Following HFE design protocols
- Any other regulatory requirements you need to meet