Diagnostic robots are increasingly used in rehabilitation research to assess overactive reflexes and increased stiffness around the joints of patients with neurological disorders, such as stroke, cerebral palsy or spinal cord injury.
SAFEharbor will develop a standardized protocol to assess the safety of such diagnostic robots, making use of the COVR toolkit and combining this with the experience we have developed over the past decades using robotic devices in patient research.
The protocol will be evaluated for two specific robots that are used in our hospitals to assess reflexes and stiffness in the wrist and ankle joints.
SAFEharbor will result in an assessment protocol that demonstrates that devices meet the Essential Requirements of the Medical Device Regulation. This represents an essential first step towards certified use of diagnostic robots in clinical practice.