Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ
Cloudbyz
AUGUST 19, 2024
Facility Controls: Ensuring that manufacturing facilities are designed, maintained, and operated to prevent contamination, errors, and defects. Packaging Integrity: Validating that the device’s packaging maintains its integrity and sterility throughout the shelf life, even after exposure to sterilization processes. In the U.S.,
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