Phase III: Small series and pilot series of diagnostics and medical products
This phase includes the design verification and the preparation for product validation. Our experts in mold design and automation engineering develop the molds for small batches and special-purpose machines for diagnostics and medical products. Mold and automation solutions are not only developed for mass production, but during the prototype and pre-production phase, which saves time. Quality planning develops the measuring equipment in the quality laboratory. If necessary, we manufacture development samples, clinical samples, or stability batches, as well as low volume commercial production in our small batch production with clean room in accordance with ISO 14644-1 ISO classes 7 and 8 or respectively GMP classes C and D. The result of this phase is a verified diagnostics or medical product.
