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EU MDR & IVDR Updates

Dec 04, 2023

Which EU Notified Bodies Are Designated Under the MDR 2017/745 and IVDR 2017/746?

Oct 17, 2023

FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know

Oct 04, 2023

FDA to Regulate Lab Developed Tests (LDTs) as Early as 2025

woman receiving laser treatment on face

Sep 19, 2023

Regulatory Requirements for EU MDR Annex XVI Devices: What You Need to Know

Aug 21, 2023

How to Transition Your Medical Device EUA to an FDA 510(k)

Aug 07, 2023

How Indications for Use Impact Medical Device Classification