Regulatory Insights

Expert articles on EU MDR, FDA, IEC 62304, and regulatory strategy for medical device manufacturers

EU MDR Implementation: What Manufacturers Need to Know in 2026

The EU Medical Device Regulation (MDR 2017/745) has reshaped the European medical device landscape. With extended transition deadlines approaching and EUDAMED milestones on the horizon, manufacturers must act now to secure market access.

Dr. Martin WalterFebruary 3, 2026

10 min read

FDAEU MDRCE MarkingRegulatory Strategy

FDA 510(k) vs EU MDR CE Marking: A Comparative Guide

Manufacturers targeting both the US and European markets must navigate two fundamentally different regulatory frameworks. This guide compares the FDA 510(k) pathway with EU MDR CE marking to help you plan a dual-market strategy.

Barry KeenanJanuary 20, 2026

9 min read

IEC 62304SoftwareCybersecurity

Getting Started with IEC 62304: A Practical Guide for Software Teams

IEC 62304 defines the lifecycle processes required for medical device software development. This practical guide breaks down the standard, explains software safety classification, and highlights common pitfalls to help your team achieve compliance efficiently.

Dr. Martin WalterJanuary 8, 2026

11 min read

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