Blog
Regulatory intelligence insights for pharma and medical devices.
What are the steps to obtain CE marking for a medical device?
End-to-end process from device classification to declaration of conformity under EU MDR 2017/745, with cited requirements for each step.
Can an AI algorithm get CE-certified as a medical device?
How to classify and CE-mark an AI/ML-based medical device under EU MDR Rule 11, with the EU AI Act obligations coming August 2026.
EUDAMED registration: what manufacturers must do before May 28, 2026
Step-by-step guide to mandatory EUDAMED registration — actor registration, UDI, device data, and legacy device deadlines under EU MDR.
FDA 510(k) vs EU MDR CE marking: what gaps exist?
If you have FDA 510(k) clearance, here's what you still need for EU MDR CE marking — clinical evaluation, GSPR, post-market surveillance, and EUDAMED.
FDA QMSR: what changed from QSR and how to comply with ISO 13485
The FDA's Quality Management System Regulation replaced QSR on February 2, 2026. Here's what changed, what's new, and how to close the gaps.