Since 2020, Silikon-Technik Siltec has been registered as a contract manufacturer of medical devices with the FDA. The FDA – the US authority for food and drugs (“Food and Drug Administration”) – monitors and administers the approvals of medical products on the US market. With the FDA registration, Siltec can produce medical silicone articles for the US market as a contract manufacturer.
For registration as a contract manufacturer, Siltec’s quality management system must meet the requirements of FDA 21CFR Parts §820 and §807. To meet this quality standard, Siltec has adapted various procedures within the company to meet the necessary requirements. For example, there is now a clearly defined process for process validation of silicone molded parts when this is required for the manufacture of a silicone product registered with the FDA.
Siltec can manufacture silicone products with FDA registration for customers using both silicone injection molding and/or silicone extrusion. This includes silicone molded parts, silicone tubing and silicone gaskets. Ready-to-use items such as ventilation tubing or assemblies can also be manufactured by agreement with the customer. In addition, Siltec can provide end-user packaging or packaging under clean room conditions by agreement.
With the registration, Silikon-Technik Siltec acts as a contract manufacturer (“Contract Manufacturer”) for the corresponding silicone products in the US market. The distribution of the products and accessories (“Legal Manufacturer”) remains with our customers.