THE IDEA BEHIND THE SMART@LIGN PROJECT IS TO REVOLUTIONISE THE DESIGN AND MANUFACTURING PHASES OF CUSTOMISED ORTHODONTIC ALIGNERS PRODUCED BY THE LEAD SUBJECT NIVOL S.R.L., THROUGH THE DEVELOPMENT OF A NEW DIGITAL PLATFORM THAT SIMPLIFIES AND INTEGRATES THE DIFFERENT ACTIVITIES? OF THE PRODUCTION PROCESS IN ACCORDANCE WITH THE INDUSTRY PLAN 4.0APPLICED TO A MEDTECH CONTEXT. THE OBJECTIVE OF THE PROJECT? OBTAINED THROUGH THE DEVELOPMENT OF A NEW COMPUTER AIDED DESIGN (CAD) SYSTEM BASED ON RULES FOR THE DESIGN OF CUSTOMISED ORTHODONTIC DEVICES, AND INTEGRATION WITH AN ADDITIVE MANUFACTURING TECHNOLOGY FOR THE DIRECT MANUFACTURE OF THE BIOMEDICAL DEVICE USING A POLYMER MATERIAL STUDIED AND OPTIMISED FOR THE SPECIFIC APPLICATION.THE REALISATION OF THE DIGITAL DESIGN PLATFORM? BASED MAINLY ON THE DEVELOPMENT AND INTEGRATION OF ENABLING TECHNOLOGIES OF INDUSTRY 4.0 (VIRTUAL GEOMETRIC MODELING, STRUCTURAL OPTIMISATION