For over ten years Scame Mastaf has produced components in which a non-conformity is not a cosmetic defect but a functional risk. In 2026 we completed the certification portfolio that brings that capability into the pharmaceutical and medical sector: ISO 13485 in March, UNI EN ISO 15378 shortly afterwards.
This page sets out what we are able to do today, under which certifications and with what documentary evidence. It contains no promises about capabilities we do not yet have.
We review your design for manufacturability at no cost: we look at geometry, material and process and tell you what can be improved before the design is closed. If complex engineering changes or a CAD redesign are needed, we quote that work separately.