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Device manufacturers in India have until May 31 to get a certificate from the International Organization for Standardization (ISO) for their quality management systems. Read More
The FDA has issued on update on Philips Respironics’ Dec. 21 recall of certain models of its Trilogy Evo ventilators, deeming it a Class 1 recall because of the risk of serious injury or death. Read More
A computer algorithm that uses retinal images was able to predict heart attacks with a 74 percent specificity, a team of researchers in the UK have reported. Read More
The point of the device history record (DHR) is to document that you carried out — accurately and completely — the activities and specifications recorded in the device master record. Read More
Selective laser therapy (SLT) is now the UK’s recommended initial treatment of choice for glaucoma, according to new treatment guidelines issued by the National Institute for Health and Care Excellence (NICE). Read More
The FDA has released new guidance that shares considerations for consulting with patient advisers to improve the conduct and design of medical device trials. Read More
The FDA has kicked off the new year with attention to medical device trials, issuing final guidance with detailed recommendations for using patient reported outcomes (PROs). Read More