Intended Use: Is the released Inten

Intended Use: Is the released Intended Use of the Medical Device following BPP HC-DIV 1074 ● Reference to the applicable Clinical Evaluation ● Reference to the applicable risk management SOPs, incl. the reference to applied hazard catalogues ● Reference to life-cycle of the device (product life-cycle): All risk management activities should refer to the product life cycle phases. During product development or product modification, a design review/ project review has to be carried out at the end of applicable phases acc. to BPP HC-DIV 370. This review is the basis for release to the next phase. The review of the risk analysis is part of the design review. The respected phase will be recorded directly in the documentation of the risk analysis. Wherever software is incorporated in a Medical device, it must be ensured to be developed following the principles of IEC 62304. ● Acceptable residual risk: Potential single risks due to product functions are assessed in the risk analysis. ● Evaluation of overall residual risk: The evaluation of the total residual risk is implemented in the risk management report. ● History file of risk analysis: All changes on risk analysis are recorded in the risk management report. ● Verification evidence: Each improvement measure for risk mitigation requires a review in two steps: 1. Review that the suggested improvement measure has been implemented and 2. a review that the risk is mitigated with this improvement measure The documentation of the review isdocumented in the risk management report. ● Responsibilities: The responsibilities within risk management process are defined in chapter 5 of this SOP. The responsibilities for execution of improvement measures for risk minimisation are recorded in the risk management report ● Definition of the expected device lifetime ● Reviewwith update of market data referring to the requirements of SOP BPPHC-DIV-001505 “Post Market Surveillance/ Post Market Clinical Follow-up Studies”
Document No.: HC-DDDD-G-4-1-05-140 - Version: 21.6 - Document ID: BPP HC-DIV 140 Document as a print out invalid 24h after: 2015-12-18 11:33 (CET)
- IMS SOP-AA - Risk Management Process for Medical Devices and Medicinal Products
B. Braun AG IMS Hospital Care Division
Document No.: HC-DDDD-G-4-1-05-140

Kết quả (Việt) 2:

D - DIV 1074 ● Tham chi các tài li - chu k - chu k Trong th để - DIV 370. Vi Giai B ● ● t ● Xác minh ch ● Trách nhi Trách nhi - DIV - 001.505 "bài Market Surveillance / Post Market Clinical Follow - lên Nghiên c "Document No .: HC - dddd - G - 4 - 1 - 05 - 140 - Version: 21,6 - Document ID: BPP HC - B. B Document No .: HC-dddd-G-4-1-05-140