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What are appropriate deviations for a LHR/DHR? (Medical Device Company)


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LHR = lot history record

What is an appropriate deviation?
Deviation to manufacturing process = Nonconforming Product = You must do all activities and record all requirements of ISO 13485 Section 8.3 Control of nonconforming product

There are no "appropriate" deviations. There are only deviations with written justifications.
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