The latest news and insights from Scarlet

Medical device cybersecurity under EU MDR: An overview of IEC 81001-5-1

EUDAMED is now mandatory. Here’s how to plan early and submit smoothly

Building SaMD under the AI Act: A practical guide

Not all AI systems are created equal: A guide to AI risk in healthtech regulation

How to use LLMs for your SaMD regulatory documentation

Why you should use Secure Data Environments to deliver PMCF for SaMD