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In Vit

Jul 28, 2023

The EU IVDR: An Overview of Regulatory Requirements in 2017/746

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

IVDR

May 15, 2023

Why Most Self-Certified IVDs Must Comply with the EU IVDR Right Now

two people looking at a laptop in an office

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