Translation procedure in ISO 13485 for medical devices

摘要

ISO 13485 is a quality management system used both by manufacturers, importers and distributors of medical devices and, to a lesser extent, translation companies specializing in this sector. Both this standard and the legislation do not specify a translation process to obtain "accurate" translations, so the process and its certification is the responsibility of the companies involved in the life cycle of a medical device, including translation companies, and of the certification bodies. In any case, it is advisable to take into account the risk classification for patients of the medical device we are going to translate and opt for the ISO 17100 translation process as a safe and proven solution to establish the ISO 13485 translation procedure and ensure compliance with it and its approval by the most demanding certification bodies.