2023-09-12T05:16:09
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.
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