MITIGATING RISK by DESIGN
Designing a medical device requires expertise in risk management for regulatory compliance and liability control. Worrell’s Human Factors Engineering team follows strict adherence to the regulatory process using the International Standards and FDA guidances, without sacrificing ingenuity. Though the FDA’s mandate is reason enough to perform HFE tasks, the benefits of these tests extend beyond making a product safer. Worrell’s Human Factors Engineering team conducts usability evaluations to produce more effective, intuitive and inclusive novel features that create competitive advantages and improve overall user experience, as well as creates on-product labeling, instructions for use and training materials.