New framework aims to make digital evidence credible for medical device regulation

University of Manchester-led researchers have unveiled a roadmap for making computer-generated evidence trustworthy enough to help regulators decide whether medical devices are safe and effective, alongside laboratory and clinical evidence. Published in the journal Device , the framework was developed by researchers from academia, industry and the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator for medicines and medical devices. The work was carried out through the UK Centre of Excellence on In Silico Regulatory Science and Innovation (UK CEiRSI), which is funded