Exoskeletons are different from any other medical device used in health-care settings. They perform “actively controlled physical interactions” with a patient, a novel feature not found in other types of medical devices.¹Navigating the requirements of a new medical standard can be difficult for manufacturers introducing products to market.

This case study explores how manufacturers can successfully overcome testing and certification challenges for RACA robots.

This case study covers the following topics:

• The growth of the medical robotics industry;
• A new standard for RACA robots; and
• Getting medical robots to market.