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Aug 08, 2022

All Class 1 Medical Device Manufacturers Must Meet These Specific EU MDR Requirements

Jul 25, 2022

List (with Links) of Important Medical Device Software Standards

business women auditing employee

Jun 09, 2022

Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor​

Clinical Evaluation Report

Apr 13, 2022

Tips for Updating Clinical Evaluation Reports (CER) and MEDDEV 2.7/1 rev 4

Apr 03, 2022

Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR

state of the art

Mar 22, 2022

State of the Art in the EU MDR: What Does That Actually Mean?