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External audits led by Subject Matter Experts are excellent ways to determine how well prepared you are for regulatory audits or simply to determine what areas need improvement.

We specialize in:

Quality System Audits (cGMP / 21 CFR Part 820, ISO 13485)

Design Control Audits

Mock FDA Audits

Design History File (DHF) / Technical File Audits

Vendor Audits

ISO 62304 Software Lifecycle Processes

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