First in Human Studies
Clinical Investigations under ISO 14155
All of Ortheia’s own technologies are sufficiently novel that they need to be tested in humans as part of the regulatory approval process for all major markets. Our team has experience in all stages of these types of study, from planning and recruiting hospitals and surgeons through to data collection and final reports.
While the majority of our experience is with medical devices, we are setting up to run Clinical Trials for ATMPs.