Oct 15, 2023
EU IVDR Compliance for In-House Lab Developed IVD Tests
Sep 30, 2023
EU MDR Equivalence: How Equivalent Does a Medical Device Need to Be According to MEDDEV 2.7/1 rev 4?
Sep 10, 2023
FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.
Jul 28, 2023
The EU IVDR: An Overview of Regulatory Requirements in 2017/746
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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