Does anyone have an example of Risk-Benefit Analysis per ISO 14971?

J

Jhintze

#1
Hi,

I am working on a Risk Management SOP to upgrade to the 2012 deviations for ISO 14971, which requires a risk/benefit analysis for all risks. This is for a contract manufacturer.

Does anyone have any examples of a risk vs. benefit analysis that you can share? I understand what it is but applying it for all risks seems daunting.

Thanks
 
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sagai

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#2
Re: Does anyone have an example of Risk-Benefit Analysis per ISO 14971 ?

It is more like a kind of professional narrative that is compiled by domain (medical) expert.
There are actually two separate wandering as far as I concern, one only for EN and that is more or less a check box that the induvidual risk including the mitigation was assessed by domain expert and was considered okay from the risk benefit prospective, the other is for all remaining/residual risks including mitigations for those, and that is for the whole device.
I do not know if the contract manufacturing covers the whole device or not though.

Cheers!
 
J

Jhintze

#3
Re: Does anyone have an example of Risk-Benefit Analysis per ISO 14971 ?

Thanks. I thought that you needed to address each risk with a risk/benefit analysis, meaning that you would need to have more than a review of each risk by a clinical expert. I thought it required that you would need to cite history/ current treatment options, etc. vs. benefits for each risk item.

A contact manufacturer probably doesn't have this information, as it would apply to the entire device, as you stated. What if their customer does not want to provide that information? With that in mind, I don't see how they can comply with the 2012 standard.
 
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