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The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs. Read More
This past spring, officials at the Saudi Food and Drug Authority destroyed millions of dollars’ worth of expired medical devices that were seized at ports, as part of a government effort to ensure products entering the country are valid and safe. Read More
Notified bodies should conduct unannounced audits of facilities that make Is/Im and in vitro diagnostic self-tests every two years if the product carries a high risk, is often noncompliant with EU regulations or otherwise raises concerns about manufacturing and quality deviations, Team-NB says in its updated industry conduct code. Read More
Industry is raising concerns about a new Turkish regulation that bans advertisements of certain medical devices and requires device sales centers to be government-certified and employ “qualified” persons. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More