Examples for documents that become easily accessible: • Tooling list of specific equipment and tools • REACH and RoHS statements • Process FMEA for all relevant steps • List of direct and indirect contact media • Safety data sheets • Information on suppliers • Initial sample test reports Additionally, we share cleaning validations and tests on biocompatibility and lifetime. In combination with a standardized, transparent process for design transfer we accelerate the time to market for your instruments and sets. Our specialty: Medical Instruments for surgeries on the shoulder, hip and knee joints as well as the spine. 187
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