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biocompatibility of medical devices iso 10993 - Hermon Labs

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CONTROL SYSTEM<br />

The testing facility should have a documented Quality<br />

Assurance Programme to assure that studies<br />

performed are in compliance with the Principles <strong>of</strong><br />

Good Laboratory Practice.<br />

Verify that the Study Plan and Study Report contains the<br />

information required for compliance with the Principles <strong>of</strong><br />

Good Laboratory Practice and Regulatory Requirements<br />

Conduct inspections to assure that the studies are comply<br />

with the Principles <strong>of</strong> Good Laboratory Practice and<br />

conducted according to the Study Plan & Standard<br />

Operating Procedure<br />

Harlan Laboratories 31

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