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Who We Are

Agilis is a full-service human factors firm first focused exclusively on the medical industry. Our medical experience includes:

  • Combination Products
  • Diagnostic Devices
  • Therapeutic Devices
  • Critical Care Devices
  • Clinical Laboratories

We provide services in four areas of focus – each one integral to seamless product clearance, approval and market success:

  1. Human Factors Engineering
  2. Evidence-based Instructional Labeling and Training
  3. Human Factors Regulatory Guidance
  4. Post-Market Surveillance

The Agilis team members use their experience and expertise to provide clear and candid input, which they deliver in a collegial and professional manner. Their integrity is absolutely impeccable and their insight is superb.
Jana Bodorova, Vice President and Head, Regulatory Affairs Strategy, Bayer U.S.


Human Factors Engineering

Our concept and early-stage design services improve usability, user satisfaction and product differentiation while changes are still easy and less costly.

Human Factors Regulatory Guidance

Our risk-based analyses of user interactions help mitigate use errors, create a human factors plan and successfully gain regulatory clearance.  

Evidence-based Instructional Labeling and Training

Agilis uses evidence-based methods to analyze user skill and performance requirements and provide an array of services for Instructions for Use and product training.

Post-Market Surveillance

Post market use problems can be a powerful resource in identifying use risks and design enhancements. Agilis employs innovative search techniques to mine use related issues from complaint and MDR narratives.
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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.”