IMDRF Issues New System for Adverse Event Reporting

The International Medical Device Regulators Form has proposed a new system for reporting adverse events related to medical devices that will provide consistency for and reduce the burden on manufacturers. Read More

Multi-Part Device Labeling, Other Issues Dog UDI Rule

The FDA’s unique device identification (UDI) rule might improve device tracking but is plagued with unresolved issues such as how to label devices with multiple components. Read More

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