Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to the newly implemented Medical Device Regulation (MDR). This article, by Diana Nogueira, helps introduce the essential updates done to ISO 14155 from its previous version and how it may facilitate manufacturers to implement the requirements for clinical investigations for medical devices. Namrata