Medical Grade Silicones are specifically designed, manufactured and purified to meet the strictest requirements of the healthcare industry. These products are made under applicable cGMP standards in facilities indirectly or directly regulated by US FDA and are typically supported with master access files.
Though there is no uniform definition, as the global leader in silicones for the healthcare industry, NuSil defines medical grade in the following manner:
How They're Made
NuSil ensures that all raw materials, intermediates, and finished products (for Medical Grade) are manufactured with applicable GMP and/or appropriate regulatory standards: cGMP 21 CFR § 820 (Device), cGMP 21 CFR § 210-211(Drug/API) and ISO 9001.
Beyond that, all these materials are manufactured under the NuSil Quality System (NQS).
How They're Supported
Our Medical Grade Silicones have extensive regulatory support (DMFs, MAFs and CEPs) and we communicate end use with the appropriate regulatory authorities.
Part of the support for our Medical Grade Silicones is opening our facilities to customer audits, upon request.
Finally, these materials are designed, manufactured, and supported for medical use. They are specifically designed to be used in the body, on the body, or in contact with the body.