Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ
Cloudbyz
AUGUST 19, 2024
Packaging Integrity: Validating that the device’s packaging maintains its integrity and sterility throughout the shelf life, even after exposure to sterilization processes. For example, the EU requires CE marking and compliance with the MDR, while the U.S. requires FDA compliance and UDI labeling. In the U.S.,
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