We are proud to announce that the article “Navigating regulatory challenges across the life cycle of a SaMD”, co-authored by our Experts, has been published in the international scientific Journal of Biomedical Informatics.

A Software as medical device (SaMD) has become part of clinical practice and the management of the development and control processes of the documentation associated with them are an integral part of many medical realities.

This work provides an integrated overview of how the European regulatory framework—particularly MDR (EU) 2017/745—and related international standards apply throughout the life cycle of Software as a Medical Device (SaMD). By mapping key regulations such as IEC 62304, ISO 14971, and ISO 13485 to each development phase, the article highlights how a structured approach can support compliance, enhance safety, and ensure effective software performance in clinical settings.

From early design and risk analysis to market placement, maintenance, and final decommissioning, each phase involves specific regulatory obligations that must be aligned to guarantee both performance and user safety.

CONTACT US FOR FURTHER INFORMATION OR IF YOU HAVE ANY QUESTION