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Ana Pilar Olmos

How to deal with changes to the device part of iDDCs?

One of the main challenges under Article 117 is determining when a device change becomes “significant.” Because the MDR and EMA provide no clear universal definition, manufacturers face a regulatory grey zone that can lead to unnecessary NBOp updates, delays, or compliance risks.

Ortzi Olasolo

GxP Validation vs SaMD in Clinical Trials

Clinical trial software must be classified correctly between GxP validation for trial support tools and SaMD regulation for software influencing patient decisions, with intended use being the key factor rather than technical complexity, since wrong classification can create major regulatory delays years later