Our

Services

We customize our services to accommodate each client’s needs and specific challenges.

Agilis Consulting Group developed and delivered on a plan that delivered excellent Human Factors data and allowed us to gain FDA clearance for our Class II medical device.

Caleb Hernandez DO, FACEP, Chief Medical Officer, CertaDose Inc.

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The Science of Human Factors Engineering

 
We examine all facets of how people will interact with a medical device or product including what they bring technically, physically, and emotionally. We incorporate our extensive experience with low literacy users to maximize first-time product success. Our proprietary human factors engineering methods seek to cost-effectively optimize device design while ensuring user satisfaction and regulatory requirements.

  • Our risk-based model evaluates safety and usability associated with users completing critical and essential device tasks.
  • Early formative evaluations ensure usability optimization, user satisfaction, mitigation of risks and use errors, and instructional labeling that effectively supports correct device use.
  • Data gathered during our processes provide evidence to regulatory bodies that the user interface has been optimized and potential device problems have been discovered and mitigated.
  • Complete turnkey services for IRB approval, subject recruitment and venue management.
  • Post-market use related issues could have a dramatic impact to product life-cycle issues including longevity and profitability. Our usability-centered post-market methods help clients to identify trends now that should be avoided in the future.

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.”