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Excellent Audit: Medical gadget companies are required to establish audit treatments and perform standard audits to ensure that their medical unit high quality administration techniques are compliant and helpful. QSR requires the audit to be performed by people who are not directly answerable for the procedures getting audited.
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EQMS by Qualsys
Though it might be remote risk, the FDA can continue to select to examine your subcontractor if you do not have the proper provider controls recognized.