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

[Roland Cooke]

Hi,

I have a Class III medical device, with no complaints in 3 years. The last Risk analysis performed was back in June 2006. No new risks have been identified.

Is it necessary to update the risk anaysis to conform to ISO 14971:2007?

The last two sentences are essentially self-fulfilling. Because you have not implemented the latest risk management techniques, you are naturally less likely to identify any new risks!

So whilst it is not yet (but soon) 'mandatory' to meet the 2007 version, you should certainly move towards doing so, and then re-evaluate the adequacy of your 2006 risk analysis, updating it as necessary.

 

[pksjdm2002]

Thank You!

 

[ropharm]

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.

Thank you ! I am new in this kind of activity and I hope to be useful for me.

 

[xcanals_tecno-med.es]

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

Hi
I see your comments in a previous post ...

Originally Posted by Bwana.Jo

Hi guys

I would like to provide my web search results before just contents and 'Foreword + Introduction' session.

*** DEAD LINK REMOVED ***
(Several month ago, I can download Eng version, but now only to read)

I believe this is not offense copyright.
If do please remove this attachment

Bwana

If you look within page 'ii' it states
"This ISO document is a Draft International Standard and is copyright-protected by ISO."

I am the responsible of the Spanish web referenced
https://www.tecnologias-sanitarias.com
and we only reproduce the index of the standards which are copyrighted material but usually reproduced by the Standarization Entities and other websites
see for example the index in english for the ISO 14971:2007 in the web from for example AAMI
https://marketplace.aami.org/eseries/scriptcontent/docs/Preview Files\149710710_preview.pdf
and Techstreet
https://www.techstreet.com/cgi-bin/pdf/preview/2323013/previews/ISO+14971-2007_pre.pdf

Sorry if someone is offended by this use, but is like the movie trailers, are only to preview some contents,
for example to know if the standard is applicable or the changes lilke in this case
must be also a general question to the standarization entties an for example the IEC publish directly this preview in their website for the published standards
See the IEC 60601-1:2005
https://webstore.iec.ch/preview/info_iec60601-1{ed3.0}b.pdf

Regards

Xavier

 

[QA4ALL]

My company is a small build to print manufacturer. We have been planning a formal ISO9001 registration and I believe that we are well prepared from a procedures and practice perspective. I was recently asked to add the ISO 13485 to our certification plans and conduct both audits at the same event. Our big customers design and market medical analytical instruments. We primarily machine many of the mechanical parts and also perform assembly of modules and sub-systems in clean room environments. I am looking for advice on how to incorporate risk managemnet requirements into our process. It seem that building to print is somewhat inconsistent with the requiremnts. Any help would be much appreciated.

 

[Roland Cooke]

There's two key things to consider:


1. "How can we screw up the order we've been given?"

2. "How can we screw up the order we've been given in a clinically-significant way?"



The second question is perhaps harder if you have no experience in the medical device field, it's harder still if you don't understand what it is you are making.


My advice is to start with Q1, perhaps use a fishbone model to formally brainstorm the ways things can wrong, and then assess the controls you have in place already to minimise them happening. The controls that aren't strong enough, beef them up.

Once you have those in place (and documented, and assessed if possible), move onto Q2. For that you can use inputs like ISO14969, Elsmar Cove, and of course input from your customer.

Once everything is in place....don't stop. Be proactive in assessing the strength of existing preventive measures, and look forward to foresee risks coming down the road. One of the biggest challenges is success....taking on too much at once!



Good luck, tell us how it goes!

 

[QA4ALL]

Thanks for the information. I will let you all know how things go.

 

[MIREGMGR]

My company is a small build to print manufacturer.

I am looking for advice on how to incorporate risk managemnet requirements into our process. It seem that building to print is somewhat inconsistent with the requiremnts.

Many aspects of medical device regulatory systems are focused on companies that have regulatory responsibility for their products. You on the other hand will be a contract manufacturer, with limited regulatory responsibility...though of course you may have any level of contractural responsibility you choose to agree to.

In any case, generally medical device risk analysis cannot proceed without extensive knowledge of device clinical functionality and clinical risk. If you don't have that knowledge, you shouldn't be responsible for such products' risk reports. You might however provide your customers with process-related risk inputs consistent with your likely greater expertise in product realization, etc., which they then can integrate into their overall analyses.

 

[k_ashwinkumar]

Can i get the annexures to review. I need a template of I4971 risk analysis guideline for suitures

 

[rdcqc]

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

Thanks for the template. I've been asked to re-vamp or existing system based on the current good practices and this is an excellent reference. Makes Appendix E a lot easier to interpret.