Blog

Jan 12, 2024

MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance

Jan 12, 2024

Supplementing Your Medical Device PMS Efforts with Online Data

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