We’re enhancing our medical device contract manufacturing services to provide full service FDA registration. Customers who previously looked to us for guidance in filing FDA registration will soon rely on us to develop, follow and complete FDA registration for medical device manufacturing.
According to the U.S. Food and Drug Administration, FDA regulation provides the framework that all manufacturers must follow by requiring manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.
Title 21 CSR Part 820 of the quality system regulation provides current good manufacturing practice (CGMP) requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. FDA registration and strict adherence to the regulation ensures that MME group medical device customers are compliant with the medical device subchapter of the Food and Drug Administration Department of Health and Human Services.
“Requirements for FDA registration are based on the device and type of activity performed on the component we manufacture for our medical industry customers,” said Mark O’Hanlon, quality lead at MME group. “On the heels of our recent ISO:13485 recertification, we look forward to becoming FDA registered .”