Risk Management Procedure updates needed for 14971:2019

bolesen

Involved In Discussions
Hi Everyone, I am new to regulatory and am trying to update our Risk Management SOP based on our last ISO auditor's feedback on improvements to our SOP.
He recommended we bolster/define the method for overall residual risk acceptability and how we evaluate residual risks.

Does anyone have any examples of how they have updated your Risk Management SOP to the 14971:2019 standard?

Any advice is much appreciated.
 

Enternationalist

Involved In Discussions
Some basic principles, to make of which what you will.
  1. Distinguish residual risk for a particular hazard from the overall residual risk in your system. One is about how much risk is left in a particular situation, the other is about considering all remaining risk together in the system. Evaluating these will generally be separate activities.
  2. Overall acceptability is normally going to come down to your risk/benefit analysis. Pretty much anything has risks - are the benefits of the device worth it, once you've considered all the little risks you add to the situation?
  3. Have clear lines about acceptability. For some devices it might be pretty easy to define a clinical standard, or typical clinical performance of similar devices, and say that if you are no worse than standard practice then that's an acceptable level of risk. For others, you might need to get clinical opinion to get an idea of what is and is not acceptable. Either way, make sure you take a sane look at the result - think deeply about how many patients would experience the type of harm you're evaluating if your device were to be in widespread use.
 

Kiranivd

Registered
I would highly recommend a process published by RQM+ for Risk- benefit analysis. Go to their blog and select this blog: A QUANTITATIVE APPROACH TO BENEFIT-RISK DETERMINATION
 

Ronen E

Problem Solver
Moderator
I would highly recommend a process published by RQM+ for Risk- benefit analysis. Go to their blog and select this blog: A QUANTITATIVE APPROACH TO BENEFIT-RISK DETERMINATION
I read the article and I don't recommend it. It applies a simplistic approach to a very complex and nuanced topic, and mostly reiterates the basics without adding any real, significant, useful insight that I could identify (not to mention some of its confident statements are downright inaccurate). I won't go into detail here and now; anyone interested is welcome to read through the many deep (and lengthy) discussions we've had here (in Elsmar), over the years, on the fascinating topics of risk management and risk-benefit analyses.

In particular, the MDR's "Risk-Benefit Determination" is far from being simple, easy, straightforward or the likes. On the contrary, it's as clear as mud, and widely-agreed quantification is practically impossible as of now. The only really useful guidance I know of on this topic is in 24971:2020 (and not for lack of search or reading). If anyone tells you it's simple, stay away!
 

Tidge

Trusted Information Resource
I reviewed the RQM+ blog post, and I don't find it to be that offensive. I agree that a specific benefit-risk analysis (for given product) requires nuance, but for a blog post I think it does a reasonable job offering a hint of how to approach the topic. Any attempt at a precise mathematical approach to (intentionally) vague rankings (typically ordinal, and not variable) is going to be a fool's errand... so maybe it is the use of the word "quantitative" in the title that is causing offense?

I have not downloaded the referenced white papers or viewed the webinar, so my comments are made absent any specific recommendations beyond the referenced blog post.
 

Kiranivd

Registered
I reviewed the RQM+ blog post, and I don't find it to be that offensive. I agree that a specific benefit-risk analysis (for given product) requires nuance, but for a blog post I think it does a reasonable job offering a hint of how to approach the topic. Any attempt at a precise mathematical approach to (intentionally) vague rankings (typically ordinal, and not variable) is going to be a fool's errand... so maybe it is the use of the word "quantitative" in the title that is causing offense?

I have not downloaded the referenced white papers or viewed the webinar, so my comments are made absent any specific recommendations beyond the referenced blog post.


Agree with you on this, however my recommendation was solely on my experience with benefit-risk analysis bearing in mind I am working with a class I medical device and we are at pre-launch. I understand that quantifying is not always possible and processes will evolve with the product. It is a good starting point for anyone new to benefit-risk alongside 24971:2020.
 

Ronen E

Problem Solver
Moderator
Bolesen, I have always likes the IMDRF documents. They have a document titled: Statement regarding use of ISO 14971:2007 Medical devises Application of risk management to medical devices.
International Medical Device Regulators Forum (IMDRF)
Quinn
Not the most relevant reference for the EU anymore - it's from 2015 and refers to ISO 14971:2007 / EN ISO 14971:2012, while the current edition is ISO 14971:2019 (and I highly recommend the 24971:2020 guidance).
 
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