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ISO 13485:2015 Pre-Release News and Discussion
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ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
ISO 13485:2015 Pre-Release News and Discussion
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ISO 13485:2015 Pre-Release News and Discussion - Page 3


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iso 13485 - medical device qms, revisions to a document or standard, iso 13485:2016
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  Post Number #17  
Old 25th January 2012, 12:54 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
Re: News on the ISO 13485 revision - 2011 - 2012

Quote:
Interesting suggestion, so that would be in the form of some kind of non-binding guidance appendix?
This would be the way, an informative annex. However, I´m pretty sure that a lot of people will oppose this idea.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!

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  Post Number #18  
Old 25th January 2012, 12:57 PM
Roland Cooke

 
 
Total Posts: 613
Re: News on the ISO 13485 revision - 2011 - 2012

Probably correctly, from the bureaucratic perspective, but I would then add the comment to the committee to address the fact that a significant minority of people/companies don't even know ISO14969 exists.....
Thanks to Roland Cooke for your informative Post and/or Attachment!
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  Post Number #19  
Old 25th January 2012, 01:00 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
Re: News on the ISO 13485 revision - 2011 - 2012

The commitee is pretty aware of that, in fact.

The real problem is that ISO 13485 is a very political document, being used or accepted in general in a lot reg systems. Any possible change to the standard will be met with resistance in principle. And one general opposition (from a lot of WG members and NCs) is that anything that is not a requirement does not fit into the document.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #20  
Old 25th January 2012, 01:03 PM
Roland Cooke

 
 
Total Posts: 613
Re: News on the ISO 13485 revision - 2011 - 2012

Maybe instead have an informative annex that just includes links (or equivalent) to these guidance sources (ISO14969, FDA guidance, MEDDEVs, whatever). Then everyone will be equally happy/unhappy....
Thanks to Roland Cooke for your informative Post and/or Attachment!
  Post Number #21  
Old 25th January 2012, 01:04 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
Re: News on the ISO 13485 revision - 2011 - 2012

Another point the committee generally is aware of is that the standard per se cannot solve all the problems of the world. For example, certification problems, which in fact is not even in the scope of the standard.

The fact that there´s a published document with guidelines and people do not know is a real shame, but a lot of people thinks that users should be aware of this because it waas written for then, and the committee should not change the standard because people are not aware of something that they should.

Although I do not totally agree with that, it is a real fact.

(i´m not really saying things in the name of WG 1 , just to be clear, but I´m just sharing the impressions I get from the meetings).
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #22  
Old 25th January 2012, 01:05 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
Re: News on the ISO 13485 revision - 2011 - 2012

Quote:
Maybe instead have an informative annex that just includes links (or equivalent) to these guidance sources (ISO14969, FDA guidance, MEDDEVs, whatever). Then everyone will be equally happy/unhappy....
Yeah, this could work, however, there´s lots of other possible solutions. The problem is, are they going to be effective?
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #23  
Old 25th January 2012, 01:08 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
Re: News on the ISO 13485 revision - 2011 - 2012

Quote:
Maybe instead have an informative annex that just includes links (or equivalent) to these guidance sources (ISO14969, FDA guidance, MEDDEVs, whatever). Then everyone will be equally happy/unhappy....
One example of the practical problems - there´s a strong emphasis not to put national or regional regulatory requirements anywhere on the standard. The standard is "aligned" with those, but there´s no mention there not to imply thet the standard is fro one or for the other.

So the only official guidance source the standard could recognize is and ISo document, or a GHTF document (the meetings are always joint with the GHTF quality system committee).
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #24  
Old 25th January 2012, 01:27 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: News on the ISO 13485 revision - 2011 - 2012

Regarding harmonization, and particularly harmonization of US FDA QSR and EU rules...is that specifically an issue for this ISO 13485 revision cycle?

I'm under the impression that US FDA and the US industry it regulates each have a faction that isn't interested in harmonization (their view being that the existing US system isn't broken and therefore shouldn't be fixed, or perhaps is somewhat broken but not in a way that harmonization would help to fix). Each also has a faction that supports harmonization but believes that US FDA's regulatory approach is more effective at achieving safety and effectiveness than the European approach. It appears to me that to the extent there is a faction within US FDA that would support FDA discarding QSR in favor of ISO 13485, that faction is weakly supported.

Of course, this is an external view of internal regulatory-body politics way above my level, and I may be mis-informed. If however this is approximately correct, then progress toward harmonization likely would entail some modifications to ISO 13485.
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