ISO 13485 certification
The Ionbond coating service centers that provide Medthin™ coatings in Europe, North America and Asia are ISO 13485-certified and employ validated systems for coating and coating processes. Full product traceability and 100% batch integrity are consequential quality attributes.
Medthin™ coatings have been tested for biocompatibility according to the ISO 10993-1 standard by independent, certified laboratories. They are approved for use with external and internal medical devices that come into contact with bone, skin, tissue or blood. For specific applications, we can provide wear simulator reports and other application-relevant tests. Some Medthin™ coatings have US FDA Master Files (MAF) that our customers can reference for clearance of Medthin™ coated medical devices in USA.