Jul 03, 2023
Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR
Jun 28, 2023
Understanding the FDA De Novo Approval Process for Novel Medical Devices
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
