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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

Mar 02, 2023

How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors

QSIT Audit

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?