Class I Medical Device Manufacturing
Cogmedix provides its valued customers with industry-leading expertise in turnkey manufacturing services for Class I medical devices.
Cost-Effective Class I Medical Device Contract Manufacturing
As a contract medical device manufacturer, Cogmedix works with innovative companies bringing their new products to market with Compliance, Competence, and Commitment.
Cogmedix also serves as a resource to 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 recognize the many benefits inherent in partnering with a compliant, competent, and competitive domestic medical device contract manufacturing company.
DEFINITION: Class I Medical Devices: General Controls Only
Class I medical devices are generally considered safe to use and are often simpler in design than Class II or Class III medical devices. These devices are subject only to general controls in the FDA Quality System Regulation. General controls cover such issues as manufacturer registration with FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. Most Class I medical devices are exempt from the good manufacturing practices and/or the FDA notification regulations. These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.
Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Depending on the “stated/purported use” of a device, it may be necessary to obtain a Pre-Market Notification 510(K) for the device, which is otherwise classifiable as a Class I device. Such devices are referred to as “reserved” devices. The electrically-powered arthroscope (which is really an endoscope powered electrically) is a case in point. While endoscopes are Class I devices, the electrically-powered arthroscopes need PMN 510(K), while the manual arthroscopes do not.