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
A company that treats regulation as paperwork feels that movement as risk. A company that has built real regulatory firepower
There is a particular kind of silence that falls over a regulatory affairs team when they realize the deadline they
I Spent the Last Week Reading Everything I Could Find on Abbott’s Libre Duo. Here Is What Genuinely Impressed Me
Let me ask you something uncomfortable….
When was the last time a regulatory submission was rejected because the threat model
Significant regulatory updates introduced across 2024 fundamentally affected medical device software within the European Union and Medical Device Single Audit