we assist entrepreuneral researchers and health care professionals as well as (startup) companies to help them build their demonstrator for preclinical investigation or build their medical device prototype and assist in the essential documentation and preparation for clinical evaluation. Our facilities and dedicated instrument makers operate under an EN ISO 13485:2012 and are certificated to ensure safe product manufacturing and assembly, suitable for clinical investigation in our hospital and partnering institutes. Other services include for example 3D printing laser cutting and marking ofmaterials, cutting and bending of materials. The main difference between UNI CEI EN ISO 13485:2016 and previous standards (UNI CEI EN 46000 and ISO 13485:2016) is to be self-supporting. Also Computer Aided Manufacturing (CAM) software to translate Computer Aided Designs (CAD) into CNC codes is available and offered as a service. The infrastructure includes several traditional milling and turning machines as well as Computer Numerical Control (CNC) machines. The Medical Device Prototyping Facility under ISO 13485 certification offers (external) researchers, health care professionals and MedTech startups and external researchers the possibility to translate their concepts into functional demonstrators and even prototypes for clinical use.
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