Class II Medical Device Manufacturing

Cogmedix provides its valued customers with industry-leading expertise in turnkey manufacturing services for Class II medical devices.

Cost-Effective Class II Medical Device Contract Manufacturing

Cogmedix is a domestic contract medical device manufacturer helping innovative companies bring new products to market with Compliance, Competence, and Commitment.

Large medical device OEMs with products that are already engineered and ready for production, are currently being built at an internal facility or by another contract manufacturer, and who understand the many advantages to partnering with a compliant, competent, and competitive domestic medical device contract manufacturing company also look to Cogmedix as a key resource in their medical device manufacturing strategy.

DEFINITION: Class II Medical Devices: General Controls with Special Controls

Class II medical devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and post-market surveillance.

Class II medical devices are held to a higher level of assurance than Class I medical devices in that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include remote health care monitoring devices, x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, acupuncture needles, and many medical lasers such as aesthetic lasers, dental lasers for soft and hard tissue procedures, and some ophthalmic surgical lasers.

See also:

Class I Medical Device Manufacturing

Class III Medical Device Manufacturing