Turnkey FDA Compliant Manufacturing

Cogmedix is an FDA-compliant and ISO 13485:2016 registered medical device contract manufacturer.

FDA Compliant Medical Device Manufacturer

Cogmedix, established in 2008 is an FDA compliant and ISO 13485:2016 registered medical device Contract Manufacturer. Cogmedix manufactures Class I, Class II, and Class III medical devices.

FDA Medical Device Regulation

The FDA is an agency within the United States Department of Health and Human Services having responsibilities for protecting and promoting the nation’s public health by monitoring and approving manufactured medical devices.

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the regulation of medical devices, as well as monitoring the manufacturing process and the performance and safety of these devices. The FDA CDRH regulates all Class I, Class II, and Class III medical manufacturing devices.

FDA CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that manufactured medical devices meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. FDA CDRH also conducts limited amounts of direct product testing.

Class I, Class II, and Class III Medical Devices

Class I Medical Devices

Class I medical devices include medical items that are very unlikely to cause serious consequences if they fail. Manufacturers are required to follow what are called “general controls” which closely match ISO requirements.

Class II Medical Devices

In addition to the general controls, Class II medical devices require a 510K clearance or a PMA approval for devices with no predicate. A Class II medical device is required to be “substantially equivalent” to existing devices. The class is now used for “medium risk” devices such as demineralized bone powder used for reconstructive surgery, which is officially substantially equivalent to plaster of paris, a much older product that was used for the same purpose. Most Class II medical devices do not require a full approval process with extensive clinical trials because of their equivalence with other devices.

Class III Medical Devices

Class III devices typically are of substantial importance supporting and sustaining human life, or in preventing impairment of human health. All Class III devices require premarket approval, including a comprehensive scientific review.