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Storage: Policy on the storage of medical device. 9. Documentation: Arrangements for the preparation, revision and distribution of necessary documentation, including storage of master documents. 10 Medical Device Complaints and Field Safety Corrective Action: (i) arrangements for the handling of complaints; (ii) arrangements for the handling of field safety corrective action. 11. Internal Audit: Short description of the internal audit system. 12. Contract Activities: Description of the way in which the compliance of the contract acceptor is assessed.
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