For over three decades, we have been helping medical device companies obtain regulatory clearance for their products. That commitment extends well beyond the sale of our silicones. We provide the technical and regulatory expertise needed for approval and are willing to communicate directly with international regulatory authorities on behalf of our customers. NuSil maintains over 700 Master Files (MAFs) with the United States Food & Drug Administration (FDA) in support of our Premium Care and Class VI products.
A critical element of the MAF is the biological testing performed on the majority of products in our portfolio.