May 15, 2023
Why Most Self-Certified IVDs Must Comply with the EU IVDR Right Now
Mar 07, 2023
Medical Device Software Changes: Getting the RA and Dev Teams on the Same Page
Mar 02, 2023
How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors
Feb 20, 2023
Understanding What Happens During a Medical Device QMS Inspection
Feb 14, 2023
What Is Considered a Significant Change Under EU MDR Article 120(3) and MDCG 2020-3?
Feb 13, 2023
An Overview of Medical Device Periodic Safety Update Reports (PSUR) and Postmarket Surveillance Reports (PMSR) Under the EU MDR
