Human Factors

Regulatory Guidance

FDA has never rejected an Agilis client’s human factors engineering submission.






Human Factors Regulatory Guidance

Agilis’ human factors regulatory guidance services offer more than conventional usability testing. Because Agilis consultants are members of the major industry standards committees; we are positioned to provide our clients with both current and forward-looking regulatory guidance. Our clients enjoy more efficient and less stressful regulatory clearance. We use a proprietary risk-based approach to human factors testing and reporting that are proven effective. FDA has never rejected an Agilis client’s submission. We help you navigate the process and accompany you to FDA meetings so you get your device cleared and to market in less time. We provide:


  • Risk-based formative evaluations and reports
  • User interaction analysis
  • Expert guidance on FDA human factors compliance based on our participation in FDA standards committees and meetings
  • Assessment of clients original human factors activities and reports with current regulatory standards and expectations
  • Summative validation testing
  • Human factors requirements for FDA submissions (PMA, 510(k), CAPA)


Clients who receive our Human Factors Regulatory Guidance services achieve:


  • Successful mitigation of use-errors
  • A human factors testing plan for FDA submission
  • More efficient FDA clearance

Human Factors Experts

The Agilis process prepares our clients to answer Regulatory’s most fundamental bottom line question: “Show us the body of evidence that provides a compelling, comprehensive and valid case that your device and IFU support safe and accurate user performance.”