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Risk Control Chart
Medical Device Risk Analysis

Medical Device Risk Analysis

Toltec offers a complete range of risk analysis services. To gain a complete perspective of risk related to your medical device, Toltec recommends that you 1) achieve compliance to ISO 14971, 2) perform a complete Failure Modes and Effects Analysis (FMEA) on your device, and 3) perform a Fault Tree Analysis (FTA) on your device. Toltec can help you in the following ways:

Hazard Identification

Toltec has experience with many types of medical devices and can assist you in understanding what hazards may exist. Examples of hazards from other medical devices:

  • Electric Shock
  • Hemolysis
  • Chemical poisoning
  • Mechanical hazards
  • Hypothermia
  • Fire
  • Etc. (Toltec has seen many other types hazards from a broad range of medical devices)


  • Provide mechanisms and definitions for Severity and Probability of occurrence (see Risk Control Chart below)
  • Provide a risk mitigation strategy
  • Provide an independent review of your existing analysis

Risk Control Chart
  Negligible Marginal Critical Catastrophic
Frequent   Intolerable    
Probable     Region  
Occasional   *ALARP   Intolerable
Remote Broadly   Region  
Improbable   Acceptable    
Incredible     Region  
* ALARP: As Low As Reasonably Possible

Note: This chart is used as a graphical indication of risk assessment. Risks are typically plotted as a function of Severity (negligible, marginal, critical, and catastrophic) vs. Probability of occurrence (frequent, probable, occasional, remote, improbable, and incredible) once risks are identified. Once risks are mitigated, the plot can be made once more to demonstrate the effectiveness of the risk management process.

Copyright 2006 Toltec International, Inc. All rights reserved.

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