Articles tagged with “medical-device-regulation”

ISO 14155 vs. ICH GCP: A Comparison for Device & Drug Trials

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

40 min read

11/22/2025

iso 14155 ich gcp good clinical practice clinical trials medical device regulation ich e6 regulatory affairs

FDA 510(k) Explained: Medical Device Premarket Notification

Understand the FDA 510(k) premarket notification process for Class II medical devices. This guide covers substantial equivalence, predicate devices, and key ste

45 min read

11/14/2025

fda 510k premarket notification medical device regulation substantial equivalence predicate device class ii medical device regulatory affairs fda clearance

AI Medical Devices: 2025 Status, Regulation & Challenges

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.

50 min read

10/30/2025

ai medical devices medical device regulation software as a medical device fda guidance eu ai act ai in healthcare algorithmic bias

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