Dec 04, 2023
Which EU Notified Bodies Are Designated Under the MDR 2017/745 and IVDR 2017/746?
Oct 04, 2023
FDA to Regulate Lab Developed Tests (LDTs) as Early as 2025
Jul 23, 2023
Understanding FDA and EU Medical Device Labeling Requirements
Jun 20, 2022
Still Maintaining Duplicate MDD/IVDD- and MDR/IVDR-Compliant Documentation?
May 22, 2022
MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance
Feb 07, 2022
The New IVDR Compliance Deadline Extension Explained