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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

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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.”