logo

QA/RA Consulting, Auditing & Training

logo

Let's get started

Blog

In Vit

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?

Safety and Performance-Based Pathway Simplifies

Sep 10, 2023

FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.

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