FDA Compliance & Usability Engineering Services for Medical Products
By applying human factors engineering early and often in the design process, use-issues can be uncovered during initial stages of development. Thus, prototypes can be refined to ensure safety, minimize costs, reduce regulatory hurdles, and maximize customer satisfaction. UserWise offers a full range of usability engineering services to support your product development.
Best-in-Class Medical Products
Our mission is to inspire best practices in human factors and usability engineering within medical device and combination product companies to facilitate the development of world-class medical products. By combining our human factors expertise with your talents in product development, together we can achieve unrivaled and safe medical innovation.
Expertise You Can Trust
From in-home injection devices to robotic surgery systems, UserWise has experience partnering with manufacturers to successfully implement the entire human factors process for medical devices and combination products. Regardless if you need a fully-equipped usability engineering team or just a one-time human factors strategy consultation, UserWise consultants offer unparalleled expertise that spans numerous medical disciplines.
Qualified Extension of Your Team
Whether you need help developing a usability engineering SOP, performing summative usability validation, or just answering human factors questions from the FDA, our human factors consultants stand ready to assist as expert members of your team. Their scientific backgrounds and extensive experience in medical product development and usability engineering allow our consultants to efficiently onboard to your technology and support your team in achieving your product development milestones.