Auditing Services

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Case Study

Auditing Services

For a major medical device manufacturer under a Warning Letter, QualityHub provided over 20 before-and-after Quality System audits of the client’s manufacturing sites in the US and Europe.  These audits allowed the company to gauge whether their quality system rebuild and remediation activities were successful. The project also involved a third visit to each of the sites to prepare them for FDA inspections.

 

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