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The FDA issued a warning letter to Eclipse Aesthetics because it had concerns that the firm’s MicroPen Elite dermabrasion device has the potential to damage vessels and nerves. Read More
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Read More
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