RENOLIT MEDICAL's Solmed products are used in the first steps in the production chain of life-saving medical devices and pharmaceutical systems. This implies that the maximum obtainable quality level of the final product is significantly influenced by the Solmed production phase. Our commitment therefore is to manufacture the best possible quality according to the specifications and requirements of our customers. The Solmed quality system is ISO 9001 and/or ISO 13485 certified to meet the pharmaceutical and medical device industry requirements. The Solmed compounds have been developed in accordance with various international Pharmacopoeias in order to meet the strictest requirements for medical applications.
Only FDA approved raw materials are used. The Solmed products are based on a unique and sensitive balance between choice of raw material, composition and processing conditions. Our documentation system guarantees full lot traceability down to a single roll of a single batch. All quality related documents, production records, test reports and samples of every roll are stored.
Raw materials, intermediate products and final products are thoroughly tested in our laboratory for different chemical parameters and cytotoxicity. Test results are registered on a Certificate of Analysis supplied with every batch of material. |
