ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

Opportunities for Smaller Software Developers Highlighted by MDCG

A new guidance from the Medical Device Coordination Group (MDCG) clarifies that software as a medical device (SaMD) product can operate under a limited amount of regulatory oversight when deployed only in a single healthcare entity, which gives smaller developers an opportunity to gain a foothold in the European Union (EU) while they add to their to-market capabilities.