UNI CEI EN ISO 13485:2021 is an international standard specifically designed for quality management systems in the medical device industries.  This standard is a voluntary guideline that defines requirements for the design, manufacture, control and distribution of medical devices, focusing on ensuring their safety and effectiveness. Companies that achieve ISO 13485 certification demonstrate a commitment to excellence in the manufacture of medical devices, thereby helping to ensure the health and safety of patients. This standard is widely recognised globally and is often a requirement for access to international markets. The first edition of ISO 13485 was published in 1996. In 2003, it was revised in order to align it with the main European directives. Subsequently, in March 2016, it was further revised. The latest update dates back to 2021. To date, the implementation of this standard provides organisations that apply it with the presumption of conformity with the mandatory requirements of the new EU Regulation 2017/745 (MDR). Unlike ISO 9001, which was also revised and published in 2015, ISO 13485 has not adopted the HLS (High Level Structure). This difference implies that companies holding both certifications (or wishing to obtain both) cannot work on both simultaneously or, possibly, find themselves having to adapt one of the two systems to the other, leading to greater effort and difficulty in the transition from the old certifications to the new ones.