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)

Analysis

• 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.