Blog
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
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