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In section 5.6.2 Implementation of risk control measures of the SOP Risk Management Procedure , it is mentionned that the effectiveness can be verified using various types of methods and data. Could you please give some examples of the methods and data that could be used ?
Thank you
Hi,
You could use for example:
* Testing
* References to statistical databases
* Monte Carlo simulations
* Literature studies
* Review of publicly available databases
* Expert assessment
Just as in “regular design verification”, you can use any method that provides objective evidence that the risk control measure is effective.
Hope this helps?
CHeers,
Peter
Sir. Would you please provide how to perform risk-benefit analysis?
Hi Wenhung,
I don’t have this in my templates, but there is some information about benefit-risk analysis in the online risk management course that you may want to check out.
Cheers,
Peter
Hazard Traceability Matrix Template: Is FMEA approach included in this template?
Hi Lucia,
FMEA is not included as it is fundamentally different than ISO 14971 risk management. You can find a comparison using this link.
/Peter
Hi Peter, thank you for your quick response. I read the suggested article. Is it correct to assume that FMEA for medical devices is then useless? Our company manufactures PCR Thermal Cyclers, and I wonder if the FMEA is ever needed and if we should go ahead with the Hazard Traceability Matrix only, as proposed in your course and video.
Hi Lucia,
FMEA is not necessarily useless, but it is most certainly not required. ISO 14971 risk management is, however, required.
FMEA is one tool that can be used in conjunction with ISO 14971 risk management, but the type of bottom-to-top analysis carried out in FMEA can also be done within ISO 14971 risk management. If you are a legal manufacturer of a medical device, you have to do ISO 14971 risk management. In all other cases, I can not advise without knowing more about your situation.
/Peter