DM2TC Sàrl Information

Medical devices technical consulting DM2TC provides advice and know-how to help industries and startups, active in the fields of biotech and medical devices, through the steps of product realization, from the idea to the marketable product: From idea to prototype: - Conceptualization and feasibility study (considering industrialization) - R&D project design & management, and scientific support - Design inputs, outputs, verification, and validation From prototype to product: - Technology transfer - Manufacturing implementation - Manufacturing control (maintenance, metrology), release tests, and processes validation From product to marketable product: - Quality system (ISO 13485, GMP) and certification - Risk management file - Regulatory files (CE marking, 510(k), PMA, HDE)