Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are vital for detecting diseases, cond...
Understanding IVDR Gap Assessment and Consulting Services for Medical Devices
Introduction to IVDROverview of IVDR
The In Vitro Diagnostic Regul...
Residual Risk Analysis and User Interaction Problems: Risk Management Under EU MDR
Under the EU MDR, Risk is defined as the combination of the probab...
MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies
The Medical Device Coordination Group (MDCG) is a regulatory body ...
Artificial Intelligence and Machine Learning for Medical Devices
In the healthcare industry, artificial intelligence (AI) refers to...
Medical Devices – USA/Europe Regulatory Updates Roundup, July 2024
USA
Medical Device User Fee Rates for Fiscal Year 2025
The Food an...
