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. Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary: An executive summary shall be provided by the manufacturer and shall contain: 1.1 Introductory descriptive information on the medical device, the intended use and indication for use, class of device, novel features of the device (if any), shelf life of the device and a synopsis on the content of the dossier.
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