An Example of a Risk Analysis Report for a Class II Medical Device (Oxygen Mask)

T

terrans

#21
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Hi,

I was wondering if you could help. I have completed a pFMEA and dFMEA for class 1 medical device.and now need to complete a risk analysis report. Would you be able to point me in the right direction of an example of a completed risk analysis report template, that I could use as a guide.

S
 
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Bill Evans

Involved In Discussions
#22
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

I was looking for guidance on the report and did not see a response here. Does anyone have a format/template?
 

Ronen E

Problem Solver
Staff member
Moderator
#23
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

I was looking for guidance on the report and did not see a response here. Does anyone have a format/template?
Clarification required please.

There are multiple references in this thread to "report". Which one are you referring to? Also, what guidance are you seeking? The more specific you are, the higher the chances someone will be able to help you.
Similarly what template are you looking for?

Cheers,
Ronen.
 

Bill Evans

Involved In Discussions
#24
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Ronen

I was looking for an example or template for a risk management Report....NOT...The ISO 14971risk management File
 

Ronen E

Problem Solver
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#25
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Ronen

I was looking for an example or template for a risk management Report....NOT...The ISO 14971risk management File
In my understanding the risk management report is a subset of the risk management file, either as an integral part of a single computer file or as a separate referred document in a paper or electronic binder. In the example provided by Steve K (post #10 in this thread) it is, in my opinion, the former - refer to the part that starts at "Estimation of Risk". Perhaps it's not what you are used to or expected to see, but in my understanding it covers a low-risk device and apparently it is fit for purpose (audit-proof). Yours might require something more elaborate or a different format, however I am not aware of a "preferred" or "standard" such format. If your measure is not ISO 14971, the contents of your report should be governed by some other frame of reference, which will determine what would be "sufficient".

If you are referring to some expectation established by the FDA, please provide more details. I'm not aware of any such well-defined expectation, but I've been through instances where FDA had field-established practices which were not backed by explicit regulations or even by published guidance (either draft or final).
 

Marcelo

Inactive Registered Visitor
#26
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

The (revised) risk management report from the 2007 versions require only one thing - the review of the process (and the answer of the 3 topics - the risk management plan has been appropriately implemented, the overall residual risk is acceptable, appropriate methods are in place to obtain relevant production and post-production information).

As most of the information is usually elsewhere, this is usually a 1-2 pages document that simply show that the plan was followed (linking to the records that show this), that the risk is overall residual acceptable (linking to the overall residual risk analysis) and linking to the pms procedures and planning.

Maybe you are confusing the report (which had a lot of other requirement in the 2001 version) with what is usually called the risk management summary that is used to show traceability and comply with 3.5 (as this was one of the things the 2001 originally required).
 
J

Jeffers

#27
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Michael,
Another beginner question, but regarding the risk management report according to ISO 14971. Our QMS is 13485:2012 and we manufacture a class II medical device. We perform clinical evaluation using literature review, PMCF and PMS activities. In the report, we draw a conclusion about risk, and obviously that "all risks that result from use of the product are outweighed by the benefits provided by the product". this is our CLINICAL EVALUATION REPORT.

As part of our technical file review, our reviewer is asking for our risk report. Can this serve as a risk report according to 14971?
 

Ronen E

Problem Solver
Staff member
Moderator
#28
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Michael,
Another beginner question, but regarding the risk management report according to ISO 14971. Our QMS is 13485:2012 and we manufacture a class II medical device. We perform clinical evaluation using literature review, PMCF and PMS activities. In the report, we draw a conclusion about risk, and obviously that "all risks that result from use of the product are outweighed by the benefits provided by the product". this is our CLINICAL EVALUATION REPORT.

As part of our technical file review, our reviewer is asking for our risk report. Can this serve as a risk report according to 14971?
the manufacturer shall carry out a review of the risk management process. This review shall at least ensure that:

⎯ the risk management plan has been appropriately implemented;

⎯ the overall residual risk is acceptable;

⎯ appropriate methods are in place to obtain relevant production and post-production information.

The results of this review shall be recorded as the risk management report and included in the risk management file.
(From ISO 14971:2007 s. 8. Emphasis added.)
 
J

Jeffers

#29
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

(From ISO 14971:2007 s. 8. Emphasis added.)
Ronen, thank you for the great feedback on this forum and the others where I have posed some questions. I am using the referenced standards, but maybe I need to be a bit more clear on my question.

I have a clinical evaluation procedure in place that results in a documented literature search every 5 years, or when any activity from PMS or PMCF reveals a cause to re-evaluate the risk profile. The results of this are written into a clinical evaluation report (CER).

Is there any reason why I cannot include a description about the risk management plan, overall residual risks are acceptable, and that appropriate methods are in place to obtain relevant production and post-production information within the CER? If I effectively communicate these points, can I title the document "Clinical Evaluation Report and Risk Management Review", and cover both points within one document?
 

Ronen E

Problem Solver
Staff member
Moderator
#30
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Is there any reason why I cannot include a description about the risk management plan, overall residual risks are acceptable, and that appropriate methods are in place to obtain relevant production and post-production information within the CER? If I effectively communicate these points, can I title the document "Clinical Evaluation Report and Risk Management Review", and cover both points within one document?
I don't see why not, but I'm not your auditor.

Just make sure that a reference in your risk management file points to that document when you get to the Risk Management Report item.
 
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