Oct 22, 2023
Medical Device Change Management Process Best Practices
Oct 16, 2023
The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval
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
