Articles tagged with “medical-device-regulation”

The EU AI Act & Pharma: Compliance Guide + Flowchart

Learn about the EU AI Act's impact on pharma. This guide explains the risk-based approach, high-risk AI rules, and compliance steps with a free flowchart & SOP

35 min read

10/18/2025

eu ai act pharmaceutical regulation ai in pharma high-risk ai compliance sop medical device regulation gxp

An Introduction to Software as a Medical Device (SaMD)

Learn the official definition of Software as a Medical Device (SaMD) from the IMDRF. Understand its scope as standalone software and its regulatory status.

30 min read

8/21/2025

samd software as a medical device imdrf medical device regulation digital health fda health tech