Remark : For more complete scenario modelling another type of Reliability analysis may be considered, for example fault tree analysis ( FTA ); a " deductive " ( backward logic ) failure analysis that may handle multiple failures within the item and / or external to the item including maintenance and logistics.
22.
Typical risk analysis and evaluation techniques adopted by the medical device industry include hazard analysis, fault tree analysis ( FTA ), failure mode and effect analysis ( FMEA ), hazard and operability study ( HAZOP ), and risk traceability analysis for ensuring risk controls are implemented and effective ( i . e . tracking risks identified to product requirements, design specifications, verification and validation results etc . ).
