Medical Grade & FDA Approved Coatings
We offer many coatings that are being used for medical devices that our customers have tested acceptable for ISO 13485:2003 and ISO 10993-1 standards.
Many coatings that we offer have met the biocompatibility testing done by our end users. These clients have tested our FDA approved coatings and they meet ISO 10993-1 for less than 24 hours of implantation for medical devices into the human body or contact with body fluids.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Our coatings offer chemical and thermal resistance. We provide custom masking solutions, as well as a single source for multi stage metal refinishing (plating, powder coating, etc).
Specialty coatings available for the following applications: