Virtual Patients Could Help Flag Medical Device Risks Missed by Conventional Studies
3 Articles
3 Articles
Virtual patients could help flag medical device risks missed by conventional studies
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.
Digital test subjects as an additional safety level: computer simulations can show how a medical device reacts to very different patient types. A new test frame is now to determine when such in-silico data is resilient enough for regulatory decisions. Using a virtual change to a heart valve, the team shows how model risk, possible damage and classic evidence are brought together. Manchester (England). Medical devices [...] The article Virtual pa…
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 medi…
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