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So many companies, so many quality systems.
Medical device companies that are merging with or acquiring companies will often be left with quality systems that have conflicting requirements, or don't align with the parent company's quality system. It's also possible that one of the quality systems may not be compliant with the FDA Quality System Regulation, EU ISO 13485, and others. In R&Q's experience with warning letters and consent decrees, it's often the lack of assessment and alignment of quality systems that results in major discrepancies, often leading to warning letters and if not quickly corrected, consent decrees.