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
May 15, 2023
Why Most Self-Certified IVDs Must Comply with the EU IVDR Right Now
