
pmid: 14515712
All of the risk analysis tables, the risk control measures, verification results, risk/benefit analyses, risk evaluations, and traceability analyses need to be documented and available for inspection by auditors. One way to organize this documentation is to have a risk management file that includes or references each of these documents.
Equipment Failure Analysis, Risk Management, Equipment and Supplies, Risk Factors, Device Approval, Product Surveillance, Postmarketing, Equipment Design, United States, Proportional Hazards Models
Equipment Failure Analysis, Risk Management, Equipment and Supplies, Risk Factors, Device Approval, Product Surveillance, Postmarketing, Equipment Design, United States, Proportional Hazards Models
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 12 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Average | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Top 10% | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Average |
