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Agilis

Transforming Science into Sales

We specialize in human factors engineering, software consulting and performance-based training and labeling for medical devices and products. Through the application of human factors methods and software solutions that lead to better and more cost-effective user performance, Agilis helps its clients achieve faster regulatory clearance, higher user satisfaction and lower post-market support costs.

Agilis consultants are experienced, world-class experts who understand the complexities of bringing a medical product to market and the importance of working in close partnership with our clients. Agilis clients have reported:

  • Faster and hassle-free compliance to FDA human factors and electronic standards and guidelines.
  • Shorter and less costly product development cycle times.
  • Improved clinical study outcomes.
  • Fewer user complaints and post-market problems.
  • Reduced use error rates and recovery times.
  • Reduced costs for user training and support.
  • Strategic advantage in an increasingly competitive market.
     
 

"Besides doing nearly nothing, I'd have to say doing a very superficial job which fails to address the FDA's main concern, namely use error that threatens patient safety...Every [human factors] dollar spent wisely yields a $3 – $10 increase in bottom-line profit."
Peter Carstensen, Former CDRH chief authority on Human Factors Engineering. Carstensen's response to most common mistakes device firms make regarding Human Factors and usability design.