21 CFR 820 - 820.140 handling
Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
During intended handling of the medical device, the product must be from the errors of mixup, damage, deterioration, contamination or any other unwanted and negative effect. To assure this, written procedures must be implement to address these aspects of product quality.
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