This has come up and is being discussed. I would appreciate feedback.

Thanks!

So far we have (listed by number):

I just remembered that some time ago the FDA section was split between medical device, pharma and qualification and validation.

I´ve always thought that including ISO 14971 for medical device risk management inside the ISO 13485 forum was a problem, because people tend to think that risk management is only a subpart of the medical device quality system requirements (when in fact risk management is the base for medical device regulations, and, thus, the "high level" requirement.....).

With this in mind, isn´t there a way to separate ISO 14971 from ISO 13485? Another option, would be to make a sub-forum on ISO 14971.

I am not so sure about separating the forum though, the definition of ISO 14971 is "Medical devices -- Application of risk management to medical devices".

Quoted from the ISO 14971:2007 standard:

1 Scope

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including
in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.

This International Standard does not apply to clinical decision making.

This International Standard does not specify acceptable risk levels.

This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

I would think sub-forum inside ISO 13485. Is that what you meant Juan?

mmantunes' suggests separating ISO 14971 from ISO 13485 but I don't think that is right, so I think if there's a forum created for ISO 14971 it should definitively be a Medical Device sub-forum.

BTW this brings up another thing kinda bothering me for some time, medical device discussion threads are currrently split in two: ISO13485 and FDA forum with it's 3 sub-forums, so some medical device discussions go into either forum but I think we need to think of a creative way to somehow integrate all of these into one.

Please feel free to post any opinions/suggestions in favor or against, all are welcome.

Ok here's suggestion #1: since ISO is universal and FDA is USA only how about making the FDA forum an ISO 13485 sub-forum and any/all of the current FDA sub-forums:
Medical Devices (21 CFR part 820) (http://elsmar.com/Forums/forumdisplay.php?f=180),
Pharmaceuticals (21 CFR parts 210 & 211) (http://elsmar.com/Forums/forumdisplay.php?f=179)
and/or Qualification and Validation (including 21 CFR Part 11) (http://elsmar.com/Forums/forumdisplay.php?f=181) (which BTW we can also consider giving 21 CFR Part 11 it's own sub-forum)

would also be ISO 13485 sub-forums or leave as FDA sub-forums.

Is Pharmaceuticals really a subset of ISO 13485? It doesn't apply to Pharma does it?

Your comments and suggestions are appreciated!

ISO 13485 emphasis is primarily on meeting regulatory requirements, and is built over the ISO 9001 platform. So I feel the major regulatory viz, US FDA, CMDR, MDD/IVD, be distinct seperate sub-forum within ISO 13485, likewise the ISO 14971.
Moderators can drag them into these sub-forum even if someone places them in the ISO 13485 main forum.

ISO 13485 emphasis is primarily on meeting regulatory requirements, and is built over the ISO 9001 platform. So I feel the major regulatory viz, US FDA, CMDR, MDD/IVD, be distinct seperate sub-forum within ISO 13485, likewise the ISO 14971.
Moderators can drag them into these sub-forum even if someone places them in the ISO 13485 main forum.

Yes, that's basically in agreement with my suggestion #1 above (paragraph 5).

BTW this brings up another thing kinda bothering me for some time, medical device discussion threads are currrently split in two: ISO13485 and FDA forum with it's 3 sub-forums, so some medical device discussions go into either forum but I think we need to think of a creative way to somehow integrate all of these into one.

One one way to do this would be do create a forum called medical device. Then, you could have sub-foruns dealingwith thing pertaining medical devices, for ex, regulatory requirements (which could inlcude sub-sub-foruns such as FDA medical device, EU medical device, Medical devices quality systems, medical device risk management, medical device usability, medical device software, etc - this would be a radica lchange but sure would benefit the discussions).

ISO 13485 emphasis is primarily on meeting regulatory requirements, and is built over the ISO 9001 platform. So I feel the major regulatory viz, US FDA, CMDR, MDD/IVD, be distinct seperate sub-forum within ISO 13485, likewise the ISO 14971.

Standards are voluntary, regulatory requirements are compulsory. Also, each regulatory system has distinctive "parts" os requirements. The main requirement is, in general, that medical devices are safe and effective during their lifecycle. This can only be demonstrated by risk management.

The "quality system" aspect of medical devices regulations is concerned with the manufacturing having a system that ensure that the manufacturer is able to produce medical devices of consistent quality. This in principle has nothing to do with safety. A manufacturer could conform to a quality system standard and consistently produce a unsafe medical device. ISO 13485 tries to remedy his situation by giving one requirement for risk management during product reealization. This was put to reflect the risk management nature of regulatory system. This does not mean that you only perform risk management because a quality system standards has one requirement for this.

This can be seen, for example, in that in the US, you have to do risk management (to demonstrate medical device safety durning it´s livecycle), and can follow ISO 14971 as it is a recognizaed consensus standard, but you cannot use ISO 13485 (because the "quality system" aspect of the US medical device regulation is dealt with GMP, which is a quality system).

Even in the EU, for example, ISO 13485 is not required (although it´s a harmonized standard and thus is best used as a means of demonstrating compliance with the essential requirements - note that ISo 14971 is also a harmonized standard).

Finally, risk management is in fact a "management system" for managing risk, just as ISO 13495 details a "management system" for managing quality.

Is Pharmaceuticals really a subset of ISO 13485? It doesn't apply to Pharma does it?

ISo 13485 is for medical devices only, not pharma.

One one way to do this would be do create a forum called medical device. Then, you could have sub-foruns dealingwith thing pertaining medical devices, for ex, regulatory requirements (which could inlcude sub-sub-foruns such as FDA medical device, EU medical device, Medical devices quality systems, medical device risk management, medical device usability, medical device software, etc - this would be a radica lchange but sure would benefit the discussions).

Let's call this suggestion #2 for conversation tracking purposes.

I'm not necessarily saying it's a bad idea but we have to look at all angles of the situation, with this in mind I would ask why create a "medical device" forum when there is already the ISO 13485 forum, FDA could be a sub-forum.

Let me say this again. FDA has regulatory requirements, which are complusory. You can use standards to fulfill regulatory requirements, or not, because standards are voluntary.

Regulatory requirements are the "high level" requirements. Any standard would be a sub-level of the regulatory requirements.

Worse, you cannot use ISO 13485 to fulfill the quality management aspect of the FDA regulatory requirements because ISO 13485 is not recognizaed by the FDA (you can only use a standard if the regulator says that it can be used to fulfill it´s regulatory requirements - it´s the same with the list of harmmonized standards in the EU).

So, there´s no logic in FDA being a sub-forum of ISo 13485 if FDA, or Medical device directive, or any other regulations, is "higher level" than any standard.

Let me say this again. FDA has regulatory requirements, which are complusory. You can use standards to fulfill regulatory requirements, or not, because standards are voluntary.

Regulatory requirements are the "high level" requirements. Any standard would be a sub-level of the regulatory requirements.

Worse, you cannot use ISO 13485 to fulfill the quality management aspect of the FDA regulatory requirements because ISO 13485 is not recognizaed by the FDA (you an only use a standard if the regulator says that it can be used to fulfill it´s regulatory requirements - it´s the same with the list of harmmonized standards in the EU).

So, there´s no logic in FDA being a sub-forum of ISo 13485 if FDA, or Medical device directive, or any other regulations, is "higher level" than any standard.

"Not recognized" does not mean "non compliant".

Thank you fot your explanation and I definitively hope to hear other people's thoughts.

Well, it's Sunday. Is the bottom line that we want ISO 14971 (which will be a new forum) as a sub-forum of ISO 13485?

Are there any other changes you folks want me to make? Other than this, is the current forum directory structure adequate and appropriate?

Here is the current layout:

http://elsmar.com/jpg/Forum outline_2.jpg
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Aerospace
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http://elsmar.com/jpg/Forum outline_1.jpg

I'm thinking just make ISO 14971 a sub-forum of ISO 13485. I *can* put 'pointers' in the FDA forums to point to the ISO 13485 forum (and vice versa) to 'connect' them.

I think that 14971 as a subforum in ISO 13485 is appropriate. I don't think that either FDA or ISO 13485 are really a subset of each other. There is definitely some overlap though. Pointers seems like the right approach.

I think we should leave FDA as a general forum. Some people who wish to post may not be definitively sure where they wish their post to go. So having a general forum for the posts seems like a decent thought; then the moderators can move it to where it should more appropriately go.

OK - Take a look and tell me what you think, please.

There is no organization that would fit all circumstances equally well, and would be clear and equally helpful to all users. The present/new layout is fine.

Well, although i still would wish a medical device forum, with ISO 13485 and other medical device standards as subforums, i have no problem with this.

But there are some areas, such as medical device usability and medical device software, which do not really fit into the existing forums, and which are hot topics (or which will become). As we´re changing the structure right now, maybe maybe we could also take this into consideration and develop sub-foruns for these also.

What i was thinking is something more like the divisions of the medical device standardization and regulatory area as can be seen in the working groups division of ISO TC 210 (http://www.iso.org/iso/iso_technical_committee?commid=54892):

TC 210/WG 1 Application of quality systems to medical devices

TC 210/JWG 1 Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices

TC 210/JWG 2 Joint ISO/TC 210-IEC/SC 62A WG : Medical device software

TC 210/WG 2 General aspects stemming from the application of quality principles to medical devices

TC 210/WG 3 Symbols and nomenclature for medical devices

TC 210/JWG 3 Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability

TC 210/JWG 4 Joint ISO/TC 210-IEC/SC 62D: Small bore connectors

Would inserting an 'FDA link' in the ISO 13485 forum be useful or more user friendly? They are so closely inter-related.

Well, although i still would wish a medical device forum, with ISO 13485 and other medical device standards as subforums, i have no problem with this.

But there are some areas, such as medical device usability and medical device software, which do not really fit into the existing forums, and which are hot topics (or which will become). As we´re changing the structure right now, maybe maybe we could also take this into consideration and develop sub-foruns for these also.

What i was thinking is something more like the divisions of the medical device standardization and regulatory area as can be seen in the working groups division of ISO TC 210 (http://www.iso.org/iso/iso_technical_committee?commid=54892):

TC 210/WG 1 Application of quality systems to medical devices

TC 210/JWG 1 Joint ISO/TC 210-IEC/SC 62A WG : Application of risk management to medical devices

TC 210/JWG 2 Joint ISO/TC 210-IEC/SC 62A WG : Medical device software

TC 210/WG 2 General aspects stemming from the application of quality principles to medical devices

TC 210/WG 3 Symbols and nomenclature for medical devices

TC 210/JWG 3 Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability

TC 210/JWG 4 Joint ISO/TC 210-IEC/SC 62D: Small bore connectors The only problem is looking at the forum as a whole right now. The top level taxonomy currently is:
Elsmar Cove Forum Essentials
Company Specific Forum(s) (Sidney's DNV forum)
Information Resources - Papers - Articles - Etc.
Students and Educational Institutions
Manufacturing, Service, and Business Systems Processes
Quality Leader's Issues in the Business Sector
Benchmarking
ISO (International Organization for Standardization) Standards
Aerospace and Aviation Requirements
National and International Business Standards
Common Quality Assurance Processes and Tools
Registrars and National / International Organizations
Professional Employment and Occupation Related
Elsmar Cove Forum Community Discussions
After Work and Weekend Discussion Topics

I have some concern as to granularity, as well. If we start listing every TAG topic we'll end up with 7 more forums, and we technically could do that for quite a few other ISO forums where there are a number of related documents. ISO 9001 comes to mind as the main one where, technically, we could add an ISO 9000 forum, and an ISO 9004 forum (as starters).

But, I'm open to suggestions. Yes - If we're going to consider a major reorganization, not to mention adding a lot of new forums, now would be the time to discuss.

NOTE: Remember there currently exist a lot of 'cross overs'. I did move as many threads to the new ISO 14971 forum as I could find, but there are plenty more I'm betting.

Would inserting an 'FDA link' in the ISO 13485 forum be useful or more user friendly? They are so closely inter-related. I put in links (Sticky Threads) to the FDA forums in both the ISO 13485 and the ISO 14971 sub-forum, just as I put in links to the FDA forums (and relate sub-forums) in the ISO 13485 and the ISO 14971 sub-forums. Is that what you are thinking of?

How about this:

http://elsmar.com/jpg/Forum rearrangement 091018pm.jpg

I liked it.

Also, please note that i was not suggesting to add the 7 ISO TC 210 WGs separations..i was worried mainly about medical usability and medical device software, which are topics already discussed here and which will become increasingly discussed due to the regulatory requirements of both these medical device areas.


The main problem here is that, although there´s at least one standard for each topic published nowadays, they are IEC standards (they were developed in the JWG of ISO and IEC with IEC lead - for the record - IEC 62366:2007 - Medical devices -- Application of usability engineering to medical devices and IEC 62304, Medical device software - Software life cycle processes ).

That´s why a topic based medical device forum, with subforums such as

- application of quality systems for medical devices
- application of risk management to medical devices
- medical device software
- medical device usability
- xxxx any other future important area of medical device regulatory and standardadization (for exemple, the IEC 60601 series)

would be better for a rearrangment, in my opinion.

But i agree with you, this would not fit the top level taxonomy right now (althoug it was done for aerospace).

Anyway, again i liked the last suggestion, and i think it´s a very good start.

How about this: ......

Under the current ISO Medical Device forum (which you circled in red), there are 2 sub forums - ISO 13485 and ISO 14971. Can we insert a link here - Link to FDA forum. That would help to make that forum appear more complete and also help those that are not that 'search' savvy.

Also, please note that i was not suggesting to add the 7 ISO TC 210 WGs separations..i was worried mainly about medical usability and medical device software, which are topics already discussed here and which will become increasingly discussed due to the regulatory requirements of both these medical device areas.


The main problem here is that, although there´s at least one standard for each topic published nowadays, they are IEC standards (they were developed in the JWG of ISO and IEC with IEC lead - for the record - IEC 62366:2007 - Medical devices -- Application of usability engineering to medical devices and IEC 62304, Medical device software - Software life cycle processes ). So - Now we have:

http://elsmar.com/jpg/Forum rearrangement 091018pm_a.jpg

and

http://elsmar.com/jpg/Forum rearrangement 091018pm_b.jpg

That´s great, i think this solves the problem.

Under the current ISO Medical Device forum (which you circled in red), there are 2 sub forums - ISO 13485 and ISO 14971. Can we insert a link here - Link to FDA forum. That would help to make that forum appear more complete and also help those that are not that 'search' savvy. Like this?

http://elsmar.com/jpg/Forum rearrangement 091018pm_c.jpg

Yes, that's what I suggested. Thanks.

Let's see what the others have to say.

Should we also have an IEC 60601 sub-forum there?

How about making the FDA subforums "Qualification and Validation" and "ISO and IEC Medical Device Related Standards" subforums from the "ISO and IEC Medical Device Related Standards" section, or at least put shortcuts there just like the FDA forum?

Should we also have an IEC 60601 sub-forum there?
That's a good idea.

Should we also have an IEC 60601 sub-forum there?

That's a very good ideia. I'd like to moderate that, also, if it's ok.

How about making the FDA subforums "Qualification and Validation" and "ISO and IEC Medical Device Related Standards" subforums from the "ISO and IEC Medical Device Related Standards" section, or at least put shortcuts there just like the FDA forum? I guess I'm getting a bit confused. Can you look at the current forum listings and explain again since I've made a few changes?

That's a very good ideia. I'd like to moderate that, also, if it's ok. OK - Added.