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recommend Software Tool for Medical Device Risk Analysis

Hello,

Can anyone recommend a software tool that really makes things easier to perform a risk analysis for a medical device?

Many companies have hazard analysis documents in which they assign risk levels to individual hazards. Using the above examples:

1. Stroke due to noncompliance to meds: occurrence 2, severity 4, risk 3
2. Stroke due to device: occurrence 1, severity 4, risk 2

Is this really good enough to assess the probability of occurrence of harm and severity of the harm? Don't we really want to know the risk of stroke alone, not the risk of stroke based on a particular hazard? 

Let's say there is a harm that is caused by 20 different hazards. Shouldn't this harm have a higher risk level than another harm with the same severity level but caused by only one hazard?
I have spent nearly 2 days reading through the many posts on these standards and also Medical Device Marketing Video to make sure I didn't simply throw out questions that were answered already, and found it to be very informative, although I still have a couple of questions left over which I would greatly appreciate some guidance on.
Please can you tell me how this is addressed in your risk management system. What is your denominator for your numeric risk levels? Is your risk per harm, per hazard, or per hazardous situation?

 

Any help will be apprecited

Thank you.

  • Hello Joe,

    We are not medical end equipment experts to provide the risk analysis for a medical device at the system level.
    Any advice we give you would be incomplete. You might want to contact companies who focus on passing the various safety and regulatory standards.