7. Quality Assurance: Description of the quality assurance system and of the activities of the quality assurance department. Procedures for the release of finished products. 8. 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.