Medical devices play an important role in enhancing patients’ quality of life and supporting the healthcare system. However, there is a need for improved methods of demonstrating their safety, performance and efficacy according to a report of a joint meeting by the Royal Academy of Engineering and the Academy of Medical Sciences.
The report, Establishing high-level evidence for the safety and efficacy of medical devices and systems, is based on a roundtable forum held on 16 January 2013 which brought together clinicians and engineers from healthcare, industry and academia along with funders and regulators.
Establishing high-level evidence for the safety and efficacy of medical devices and systems