The type of eQMS That Should Have Existed by Now
The global regulatory landscape for Software as a Medical Device (SaMD) has reached a definitive inflection point as of March
Kalpesh Hegde
August 8, 2026
The global regulatory landscape for Software as a Medical Device (SaMD) has reached a definitive inflection point as of March
Scroll through any regulatory forum right now and you’ll find the same fight: is this feature Class I or Class
There is a particular kind of silence that falls over a regulatory affairs team when they realize the deadline they
Significant regulatory updates introduced across 2024 fundamentally affected medical device software within the European Union and Medical Device Single Audit