The Final Draft of the ISO 14155 has been released. The standard has many areas that are updated significantly. The update came from various sources besides continuous improvement, increased risk based approach (both for the investigational device – ISO 14971 as well as regarding the conduct of the clinical investigation itself), EU MDR, a stronger need for study design including statistical aspects, defining types of clinical investigations, and how ISO applies to each of them. Many subject matter experts have contributed to the many changes in this version of the standard. This workshop will provide you with an overview of the main changes, bring important information on the conduct of international clinical investigations, and how the standard concurs with the new EU-MDR requirements for clinical investigations.