Our Services

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

 
 

Human Factors Regulatory Guidance

FDA has never rejected the human factors regulatory strategy from an Agilis client. Industry is feeling the pressure from increasing regulatory scrutiny on a global basis. 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. We help you navigate the regulatory process including representing you at regulatory meetings to support your successful submission the first 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 regulatory submission

  • Reduced regulatory stress