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In a move aimed at ensuring the safety and effectiveness of marketed products, the FDA has updated its thinking on 522 postmarket surveillance studies for Class II and III devices. Read More
The FDA has provided details on how it plans to regulate diagnostics that detect infectious disease organisms, antimicrobial resistance and virulence markers. Read More
Malaysia’s Medical Device Authority is encouraging companies to include information on how long it will take to complete the recalls in standard operating procedures. Read More
Aiming to improve the safety of medical device connections in clinical settings, ISO has published a new standard on neuraxial applications for small bore-connectors. Read More
Traditional study designs are the most suitable way to demonstrate performance of liquid chromatography-mass spectrometry in vitro diagnostic devices, despite their complex nature. Read More
With mobile medical apps to track fitness and monitor other vital signs, developers have many questions — and seemingly few answers — on how their products will be regulated. Read More