Contract Medical Manufacturing at Cogmedix

Cogmedix, established in 2008 is an FDA compliant and ISO13485:2003 registered medical and clinical device Contract Manufacturer. Cogmedix manufactures Class I and Class II medical and clinical devices.

FDA Standard Medical Device Manufacturer

FDA CDRH – Center for Devices and Radiological Health

FDA Standard ManufacturerThe 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 pre-market approval of all medical devices, as well as monitoring the manufacturing process and the performance and safety of these devices. The FDA CDRH regulates all Class I and Class II 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. CDRH also conducts limited amounts of direct product testing.

Class I Medical Devices and Class II Medical Devices - Cogmedix

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.

In addition to the general controls, Class II medical devices require an approval. The intent of this class was for new manufacturers of devices that already existed when the rules were established. 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.

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Cogmedix – 70 Hartwell Street -– West Boylston, MA 01583

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