Covers definition
Examples of Covers in a sentence
Covers applicability of device-specific standards, the rationale behind using the standard and scientific methods of investigation during device design and packaging development to support the device safety, efficacy, effectiveness and risk.
RIFC-US-04- DOP Document Preparation Includes: Covers sharing the templates of the SOPs per ISO 13485 and 21 CFR 820 requirements and hands-on training on preparation of important and mandatory documentation (based on the shared templates) like standard operating procedures, validation protocols & reports, quality manuals, Device Master Files (DMF), Design History Files (DHF), Site or plant master files, package inserts (IFU), primary and secondary packaging material symbols and text, etc.
RIFC-US-05- DOR Document Review Includes: Covers review of important and mandatory documentation like standard operating procedures, validation protocols & reports, quality manual, Device Master File (DMF), Design History File (DHF), Site or plant master file, package inserts (IFU), primary and secondary packaging material symbols and text, etc against the ISO 13485 and 21 CFR 820 requirements.
Risk management plan, Risk report & matrix RIFC-HP-01- ADV General Advisory Includes: Covers advise on the applicability of the US FDA Health Insurance Portability and Accountability Act (HIPAA) for your device.
Other Addresses and Other Information (Covers forms and publications addresses and official use information) See Annex A to Schedule 3 (DEFFORM 111) DEFFORM 111 (Edn 02/16) Appendix - Addresses and Other Information 1.