Blog

Jan 12, 2024

Preparing for a Notified Body Medical Device Clinical Audit

Jan 12, 2024

The New IVDR Compliance Deadline Extension Explained

Jan 11, 2024

Evaluating and Accepting Medical Device and IVD Residual Risk

Jan 11, 2024

FDA Oversight of AI and Machine-Learning Medical Devices

Jan 11, 2024

Complying with EU IVDR Postmarket Surveillance (PMS) Requirements

Jan 11, 2024

How FDA Distinguishes Between Medical Device Servicing and Remanufacturing