ISO 13485 Certification

Ionbond’s coating service centers for Medthin™ coatings in Europe, North America and Asia are ISO 13485 certified and employ IQ, OQ, PQ process validated systems. Full product traceability and 100% batch integrity are consequential quality attributes.

Biocompatibility

Medthin™ coatings have been independently tested for biocompatibility according to the ISO 10993-1 standard. They are approved for use with external and internal medical devices that come into contact with bone, skin, tissue or blood. Medthin™ coatings have US FDA Master Files for Medical Devices (MAF).