Quality & Regulatory Support

For More Information Call: 1-800-296-5893

Quality inspection

Coeur OEM is registered with the FDA as a manufacturer, a contract manufacturer, and a re-packager/re-labeler of medical devices. Coeur Medical meets the current requirements of FDA’s QSR (Quality System Regulation), formerly the cGMP (Current Good Manufacturing Practices) and has a CEMA (Controlled Environment Manufacturing Area) that controls 0.5 micron and larger particles.

Coeur OEM is an ISO 9002/EN46001 Certified Assembler of Medical Devices, and our Quality System has been recommended for ISO 9002 Certification as an Injection Molder of Medical Components.

Coeur OEM provides regulatory support (including 510(k) submissions and sterilization) to the medical marketplace. Coeur Medical can also coordinate material testing for biocompatibility or physical properties.

Coeur OEM provides a full range of inspection and testing capabilities including: