Overall Residual Risk Procedure based on the 2007 version of ISO 14971

[jscholen]

I have been unable to locate an thread specifically addressing my need:

Has anyone implemented a Overall Residual Risk evaluation procedure based on the 2007 version of 14971. How are you evaluating and quantifying OA RR?

Thanks.

 

[BradM]

Re: Overall Residual Risk Procedure

Well hello there!

I don't think I have seen anything on this. Maybe some of the other Covers have experience in this. It's coming up on the weekend, so the posts may be a little lighter over the next couple of days.

 

[yodon]

Re: Overall Residual Risk Procedure

I'll jump in... if nothing else to maybe stimulate discussion.

Our clients have pretty much just made a statement in the Risk Report that the overall residual risk is considered acceptable. None (yet) have been called to the mat.

 

[Marcelo]

Re: Overall Residual Risk Procedure

I´m moving this thread to the new ISO 14971 forum. Maybe there we will have more comments from other covers.

 

[MIREGMGR]

Re: Overall Residual Risk Procedure

(...) made a statement in the Risk Report that the overall residual risk is considered acceptable.

In our device-family risk reports to date, we have addressed this question with a conclusion as above, following a brief analysis of the worst case summed risks from the individual analyses, and a (subjective, expertise-based) review of whether the individual risks have any potential for synergizing each other. We support "acceptable" with a brief review of the general benefits to be delivered per the Intended Use, the practical alternatives to the use of the device and their general risk positions as we perceive them, and therefore the "cost-effectiveness" of our device family in a risk sense.