The use of colorant and additive solutions in medical applications requires technical and regulatory expertise to ensure that FDA regulations or industry standards are met. Colorant compounds or concentrates are often used in plastic surgical tools, prosthetics, catheter tubing and dental tools.
Our technical experts have a detailed knowledge of FDA regulations, and FDA-drug master files are available when required. Our company is accredited by A2LA for ISO 17025 and certified to ISO 9001, and has a regulatory affairs manager on staff to assist with compliance guidance for drug master files and UL standards.
Plastics Color knows how precise medical application development needs to be. Safety and function are of paramount importance. Contact Plastics Color today to see how our experience in this area can help you.