DM2TC homepage

DM²TC provides advice, know-how and hands-on work to help industries and startups, active in the field of medical devices (also including or even being software), through the steps of product realization, from the idea to the marketable product:


Conceptualization and feasibility study R&D project design & management according to ISO 13485 and 21 CFR 820 requirements (including documentation of design inputs, outputs, verification, & validation) Support for building up technical file or design dossiers, including risk management, usability engineering, ...		Technology transfer Manufacturing set up, implementation and control (including qualification and control of subcontractors & suppliers, metrology, environmental controls, maintenance, in-process and release tests, batch records, ... Special processes validation (packaging, sterilization, ...) Cleanroom management		Quality management system (ISO 13485, 21 CFR 820) implementation and support through certification Regulatory files (CE marking, 510(k), PMA, ...) and help through certification/approval process Market access regulatory submissions Post-production (post-market) surveillance Internal audits, trainings, ...