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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.

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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.
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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.  
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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.
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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.”