Your trusted human factors partner for the global medical market


 
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Agilis Mission Statement

Agilis is your trusted human factors partner for the global medical market. We help new and established companies achieve successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. Agilis’ proven human factors strategies, process and expertise drive regulatory success and speed to market –
the first time.

 

Agilis is a recognized industry-leading global medical market human factors firm with a reputation of delivering high quality results, having a deep understanding of regulatory nuances all while maintaining the highest integrity. Since 2000 we have helped our clients achieve regulatory clearance with higher user satisfaction and lower post-market support costs for combination products, diagnostic, therapeutic and critical care devices and clinical laboratories.

News Flash

Sponsors often ask us, “Can we do a threshold analysis instead of submitting human factors validation data to the agency?” The short answer is: It depends! Read More>>


Services

Our proprietary human factors engineering methods seek to cost-effectively optimize device design while ensuring user satisfaction and regulatory requirements.

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.
 

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.

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.
 

Evidence-based Instructional labeling & 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.


“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 Napolitano, Vice President and Head, Regulatory Affairs Strategy, Bayer US

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Global Experience

Our clients count on us to understand their specific regulatory environments and provide experienced guidance to help ensure the fastest and most complete studies and reports. We customize our services to meet each client’s needs and specific challenges.

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“Agilis is a superb partner for human factors testing. Their deep experience and expertise were critical in successfully developing and executing complex studies within very aggressive timelines. We needed to recruit subjects of all ages and literacy levels to evaluate use of our in vitro diagnostic by a broad demographic. Agilis handled this difficult project with flexibility and creativity, addressing risks proactively while ensuring the highest quality data. The entire team we worked with was excellent, always providing professional, clear, and timely communication. Agilis will always be our first choice for any human factors project in the future.”
— Carol Chen, PhD Director of Regulatory and Clinical Affairs Diassess Inc.

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Our Team

Agilis’ team are all seasoned human factors experts, many of whom are considered industry thought leaders. We strive to maintain consistency of your Agilis team throughout the project lifecycle. Our unabashed commitment to quality is evidenced by a rigorous internal quality control system including on-going professional development for all Agilis team members.

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 user interface and labeling support safe and accurate user performance."