Can your company prove its device has been manufactured in accordance with its DMR?
When applicable, the process provides novel products with a speedier route to market.
The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.
Managing suppliers is critical, and your processes in doing so must be documented.
Failure to comply with FDA’s wishes landed three companies warning letters.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Audits are the cornerstone of a QMS.
In many cases, establishments are removed due to a failure to renew annual registration with the agency.
The Banyan Brain Trauma Indicator was authorized through the agency’s Breakthrough Devices Program.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.