Application of Risk Management - ISO 14971:2007(E) Medical Devices

[minaadel]

Re: ISO 14971:2007(E) Medical devices — Application of risk

dear sir
what i mean that iam new un this farm and i read the standared but how can i start what is the proceduer to generate a risk management file for that i need a model for any medical device risk analysis which can help me in understanding ....i hope my words can be easily understanded

 

[minaadel]

Re: ISO 14971:2007(E) Medical devices — Application of risk

dear sir
can u help me in creating my risk analysis file as i donot know how can i start ,for that can u send a model like what u did in annex E
thx for ur support

 

[kingkingwang]

Re: ISO 14971:2007(E) Medical devices — Application of risk

I've created a Draft of a Risk Management Report based on Annex E of 14971:2001. This document has not been checked or approved, I hope this might be used a guide.
Please look at it and make comments on it for this forum.

DO you have another part of the risk management report

 

[minaadel]

Re: ISO 14971:2007(E) Medical devices — Application of risk

dear sir
i want to make a risk mangement file according to iso 14971:2007 but i didnot understand it well for that can u send me a model for it for any medical device
i will be very thankful

 

[cf252]

Re: ISO 14971:2007(E) Medical devices — Application of risk

I am undertaking a risk assessment in accordance with BS EN ISO 14971:2007 Annex E ie. Application of Risk Management to Medical Devices to support the registration of a medical device in accordance the the EU Directive.

For such an assessment, the probability of occurance is a factor in the Acceptance Criteria. However, I have been unable to determine whether the probability is per use or per year or per patient etc.

I am assessing a device that will be used for about an hour or so a day and therefore there is a significant difference between a probability of occurance being per use or per year. Any help, guidance and/or interpretation of this part of the Standard would be much appreciated. Many thanks.

 

[Marcelo]

Re: ISO 14971:2007(E) Medical devices — Application of risk

As the manufacturer YOU use the probability that you think is the best one that fits the hazard.

Remember that ISO 14971 has to be applied during the product lifecycle. So one way is to use the probability of continuous use, even if the equipment is used just one hour per day (you really have to know the expected lifecycle of the device, anyway).

Another way is to separate the probability between uses.

I think the best way would be a combination of both, just to keep it safe.

 

[cf252]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Thank you for an interesting reply. My background is the nuclear industry where probabilistic risk assessments are performed on a few plants used by highly trained operators and highly instrumented systems.

I am now assessing a medical device used by over 100,000 members of the public each year. The probability of most user initiated events happening is basically 1 amongst all the devices, but I can consider this on a per device basis.

Fortunately, the consequences of most of these events is minor and usually not life-threatening; as long as some basic common sense is employed even without reference to the user instructions and safety advice! However, people can do some very strange things at times ... !!

 

[Marcelo]

Re: ISO 14971:2007(E) Medical devices — Application of risk

If that´s the case, you should really focus your risk management on the output of your usability specification analysis, as home-care devices are best assessed this way. The fact that the requirements for training for the use of your device are almost none (i´m guessing, but this is usually the case on home-care devices) means that risk control measures have to be intrinsic to the devices, rather than relied upon on user attention and skills and warning notices and alarms.

 

[QA-Man]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Ironically, the document that started this post (posted by my co-worker, a great team member) has been retired. Our organization recently integrated risk analysis and design control into one process (which is probably the intent of the standard)

The core idea behond Risk Analysis & Management is:

At each stage of product development (from concept to post-market) you must say "what are the risks", "are there any dangers", "what can go wrong", and "how can someone make a mistake.

If you find a potentional hazard you must say, in the following order, "can we reduce this by changing the design (round instead of sharp edges)", "can we reduce this by some protective measure in the device or manufacture of the device (like an alarm in the device)", and "can we reduce this with information (warning label or good instructions for use)"

Finally, you must document when you asked yourself these questions, what the answers were .

There are many ways you can do this but the way you document should be suited to your organization's needs and resources.

 

[WBubel - 2010]

Re: ISO 14971:2007(E) Medical devices — Application of risk

I am currently working with QA-Man on taking a existing product and appling the new process to it (as described in his post).