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Class Ii Medical Device Articles & Analysis
3 articles found
Many cell and gene therapy solutions have shown considerable promise as a source of possible treatments for a wide range of chronic disorders. However, these sophisticated therapies introduce additional barriers such as the requirements for ultra-low and cryogenic storage, which affect numerous steps of the biomedical solutions’ life cycles, from their development to their administration. ...
An optimised biomedical cold storage environment, especially when equipped with Ultra-Low Freezers, can reliably store even the most thermosensitive biological samples for research purposes. In recent years, several beneficial cell samples and microbial strains have been discovered, engineered, and studied. As a result of these scientific discoveries and other technological breakthroughs, ...
The US Food and Drug Administration (FDA) requires that all medical devices are identified with a unique device identifier (UDI), in both human and machine-readable forms. These UDI regulations were put in place to enable healthcare providers and manufacturers to more quickly identify flawed devices, leading to faster recalls, and a reduction in medical errors. UDI regulations UDIs are unique ...