Consulting services and specialized training courses include : - Preparation and compilation of technical files based on MDR and MDD 93/42/EEC directive . - Quality management system based on ISO 13485:2016 - Design process ( Design verification / Design validation ) - Risk management based on ISO 14971:2019 - PMS ( Post Market Surveillance )/PMCF/PSUR - Clinical Evaluation - Usability Engineering based on IEC 62366-1:2015 - Medical device software - Software life cycle processes ( IEC 62304:2006/Amd 1:2015 ) - ( UDI ) Unique Device Identification
