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The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More
Indian devicemakers, together with governmental and nongovernmental partners, have formed a steering committee to push a self-certification proposal for manufacturing best practices. The aim is to ensure the quality of Indian devices and eliminate sales of substandard products. Read More
The EU was set to sign on as a full observer to the International Medical Device Regulators Forum’s single audit program when the group met in Tokyo in late March, according to an FDA official familiar with the talks. Read More
Devicemakers soon will start feeling the impact of the Center for Devices and Radiological Health’s inspectorate overhaul following the addition of quality-driven metrics and pre- and postapproval confirmation of controls audits, a center official says. Read More