Understanding UDI Requirements for Medical Devices: A Comprehensive Guide
The Unique Device Identification (UDI) system is a global initiati...
Usability Testing in Medical Devices: A Comprehensive Guide
Usability testing in medical devices is an essential aspect of ens...
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...
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...
US FDA Requirements for Design Verification and Design Validation Activities
What is Design Verification?
Design Verification is a critical ste...
