Class III Medical Device Manufacturing
Cogmedix provides its valued customers with industry-leading expertise in turnkey manufacturing services for Class III medical devices.
Class III Medical Device Contract Manufacturing
Cogmedix works closely with global innovators bringing new products to market with Compliance, Competence, and Commitment. A trusted contract medical device manufacturer, Cogmedix also serves as a valuable outside resource to large medical device OEMs with products that are already engineered and ready for production, are being built internally 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 III Medical Devices: General Controls with Special Controls and Pre-Market Approval
A Class III device is one that has generated insufficient data to accurately assure its safety and effectiveness solely through controls which would otherwise be appropriate for Class I and Class II medical devices. The primary difference is that, in addition to the general controls of Class I and special controls of Class II, all Class III devices require premarket approval, including a comprehensive scientific review to ensure the device’s safety and effectiveness.
Class III devices typically support or sustain human life, are of substantial importance in preventing impairment of human health, or, simply by its use as intended, presents a potential, unreasonable risk of illness or injury.