Preventing Medical Device Recalls

Preventing Medical Device Recalls

Raheja, Dev

Taylor & Francis Ltd

10/2024

230

Mole

9781032926377

Pré-lançamento - envio 15 a 20 dias após a sua edição

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Overview of Medical Device Requirements. Preventing Recalls during Specification Writing. Risk Assessment and Management. Preventing Recalls during Design and Development. Preventing Recalls during Production. Preventing Software Design Recalls. Preventing Supplier Quality Defects. Preventing Recalls during Verification and Validation. Validation Testing to Discover Design and Manufacturing Errors. Preventing Recalls during Field Monitoring. Planning for Potential Recalls to Maximize Efficiency in the Event of a Recall. Role of Management in Preventing Recalls. Appendix.
Medical Device Recalls;PHA;fault;FMEA;tree;Medical Device;analysis;Food And Drug Administration;preliminary;FDA;hazard;Process FMEA;failure;FDA Website;mode;Follow;infusion;CFR;pump;User Facility Device Experience;design;HACCP;PCA;FTAs;FDA Quality System Regulation;Design FMEA;User Errors;Vice Versa;FDA Recall;Fault Tree;Disengaged;Electronic Health Records;Infusion Pumps;Minimum Life;Device Failures