FDA Cleared Medical Device — Product certification required by law to commercialise medical products in the United States. Cleared medical devices are those that the FDA has determined to be substantially equivalent to another device(s) that is already legally marketed. A premarket notification must be submitted to the FDA on the part of the manufacturer in order to obtain a clearance.
ISO Certified — Standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 specifies the requirements for quality management systems that an organization or company needs to be able to demonstrate with respect to its ability to provide medical devices and any related services that consistently meet the requirements of its customers as well an applicable regulatory agency.
CE Marking — Product certification required by law to commercialise medical products in the European Union. The “CE”marking on a device is the manufacturer’s disclosure to indicate that the device in question complies with the essential requirements of the European Union with regards to health, safety, and environmental protection legislation.