The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > IEC 62304 - Medical Device Software Life Cycle Processes
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
2013, iec 62304 - medical device software life cycle processes
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  #1  
Old 4th May 2012, 08:20 PM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is offline
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,190
Thanks Given to Others: 317
Thanked 1,633 Times in 875 Posts
Karma Power: 276
Karma: 11754
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Look! Update on IEC 62304 revision - May 2012 - 2013 (TBD)

Hello all

ISO TC 210 JWG 2 met this week to further discuss the revision of IEC 62304 (and the creation of IEC TR 80002-2).

We've finally managaed to come to mature the working draft enough to circulate a first committee draft.

The main idea behind the revision is to clarify some confusing parts of the standard, for example, to clarify software safety classification issue.

Another interesting development was the addition of an annex to deal with legacy software (software created before IEC 62304 was created and still used today). It follows the same idea of the legacy annex to the usability standard (62304) to permit that manufacturrs follow an alternative process when applying IEC 62304 to legacy software (otherwise all software would need to be redesigned to meet the standard :-)).

For those which can have access thru the National Committes, expect a CD in the following months.

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

Sponsored Links
  #2  
Old 5th May 2012, 02:55 AM
sagai sagai is offline
Appreciated Information Resource

 
Registration Date: Oct 2009
 
Posts: 1,065
Thanks Given to Others: 448
Thanked 369 Times in 264 Posts
Karma Power: 129
Karma: 2318
sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.
Re: Update on IEC 62304 revision - 4 May 2012

One of the improvement would be good to see once as regard to this standard is to remove the sequential determination of tasks and to really enable its usage in a non waterfall environment.
I would really challenge if anyone is indeed conforming with this standard on an implementation level in the industry, anyway.
Sponsored Links

  #3  
Old 5th May 2012, 10:22 AM
glork98's Avatar
glork98 glork98 is offline
Involved in Discussions

 
Registration Date: Jun 2010
Location: Minneapolis
 
Posts: 72
Thanks Given to Others: 4
Thanked 60 Times in 24 Posts
Karma Power: 23
Karma: 314
glork98 is appreciated, and has over 300 Karma points.glork98 is appreciated, and has over 300 Karma points.glork98 is appreciated, and has over 300 Karma points.glork98 is appreciated, and has over 300 Karma points.
Re: Update on IEC 62304 revision - 4 May 2012

Quote:
In Reply to Parent Post by sagai View Post

I would really challenge if anyone is indeed conforming with this standard on an implementation level in the industry, anyway.
Doing my best, every day!

I think 62304 can be followed with an agile process but re-doing the requirements, architecture and design docs frequently would be a big hit on productivity. It does work best for projects that follow a waterfall approach.

For clean-sheet products where waterfall is the best approach (IMHO) following 62304 is quite natural.
  #4  
Old 5th May 2012, 01:00 PM
sagai sagai is offline
Appreciated Information Resource

 
Registration Date: Oct 2009
 
Posts: 1,065
Thanks Given to Others: 448
Thanked 369 Times in 264 Posts
Karma Power: 129
Karma: 2318
sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.sagai is appreciated, and has over 1700 Karma points.
Re: Update on IEC 62304 revision - 4 May 2012



It is hard to believe if there is any project recently can afford to do a waterfall life-cycle.
Do you know any?
I am not referring to the ones pretend to be compliant by management and quality folks, but when really, I mean really no coding occurs prior having all the requirements defined in accordance with the flavor of 62304.
I have seen enough fake implementation saying, oh yes, it is 62304 compliant, however and of course, it was very not the one on the developers level.

I seriously do not believe anyone can survive without continuously deliver running software to customer during the design phase in order to validate it and this is actually not really the way defined in a sequential, hierarchical model of 62304 (I know it is defined any model is okay, but for me it just does not really support other than the waterfall life-cycle).

But I am open to learn and see examples, that is one of the reason I spending my time here sometimes.

  #5  
Old 6th May 2012, 01:28 AM
Gert Sorensen's Avatar
Gert Sorensen Gert Sorensen is offline
Forum Moderator

 
Registration Date: Apr 2006
Location: Denmark
Age: 46
 
Posts: 1,261
Thanks Given to Others: 714
Thanked 491 Times in 304 Posts
Karma Power: 166
Karma: 3836
Gert Sorensen is appreciated, and has over 1700 Karma points.
Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.
Re: Update on IEC 62304 revision - 4 May 2012

I am very much looking forward to the draft being available to industry in general, especially because of the clarification of software classification. Too bad though, that it will require access through the national committees. Will it be made available for comment by industry at a later stage?

__________________

Beetle Bailey Rules! :)
  #6  
Old 7th May 2012, 11:58 AM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is offline
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,190
Thanks Given to Others: 317
Thanked 1,633 Times in 875 Posts
Karma Power: 276
Karma: 11754
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: Update on IEC 62304 revision - 4 May 2012

Quote:
One of the improvement would be good to see once as regard to this standard is to remove the sequential determination of tasks and to really enable its usage in a non waterfall environment.
I would really challenge if anyone is indeed conforming with this standard on an implementation level in the industry, anyway.
There´s no suggestion to change anything related to this matter at the moment however...

IEC 62304 does not require an waterfall lifecycle model, nor a sequential determination of tasks. Not sure why you said that those are requirements.

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
  #7  
Old 7th May 2012, 12:03 PM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is offline
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,190
Thanks Given to Others: 317
Thanked 1,633 Times in 875 Posts
Karma Power: 276
Karma: 11754
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: Update on IEC 62304 revision - 4 May 2012

Quote:
I am very much looking forward to the draft being available to industry in general, especially because of the clarification of software classification. Too bad though, that it will require access through the national committees. Will it be made available for comment by industry at a later stage?
No, standards development are always performed by WG members and participating NCs. Sometimes (case of the revision of ISO 13485) some input from outside the committees is wanted, but it´s only informal in the way that it´s not included in ISO/IEC rules.

Just as a curiosity, why do you think it´s bad? The idea is that the industry needs to participate in standards development, but needs to do it thru the NCs (which in fact are the only members of ISO/IEC).

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
  #8  
Old 8th May 2012, 02:43 AM
Gert Sorensen's Avatar
Gert Sorensen Gert Sorensen is offline
Forum Moderator

 
Registration Date: Apr 2006
Location: Denmark
Age: 46
 
Posts: 1,261
Thanks Given to Others: 714
Thanked 491 Times in 304 Posts
Karma Power: 166
Karma: 3836
Gert Sorensen is appreciated, and has over 1700 Karma points.
Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.
Re: Update on IEC 62304 revision - 4 May 2012

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

Just as a curiosity, why do you think it´s bad? The idea is that the industry needs to participate in standards development, but needs to do it thru the NCs (which in fact are the only members of ISO/IEC).
Unfortunately, not all of us in industry has a seat with the NC
So, basically, we don't have any idea what the NC is working on (at best we have an idea of the overall scope, but definitely not a more detailed knowledge of what the focus of the WC is). If you - as an industry professional - have a natural interest in what changes are coming within your field of expertise, then it is a little bit sad that you can't have access to some of that information. Just my

__________________

Beetle Bailey Rules! :)
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > IEC 62304 - Medical Device Software Life Cycle Processes

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
IEC EN 60601-1-4 vs. IEC EN 62304:2006 Gap Analysis? peter_traina IEC 62304 - Medical Device Software Life Cycle Processes 6 13th May 2013 12:05 PM
Was EN 980:2008 superseded by EN 15223-1:2012 on January 31, 2013 Bhimaram CE Marking (Conformité Européene) / CB Scheme 2 9th April 2013 05:31 AM
Closed or Resolved: CloudFlare Bug Report Thread - 2013-03-24 to TBD (Debug In Process) Marc Forum Suggestions, Complaints, Problems and Bug Reports 16 27th March 2013 04:25 AM
IEC 62304 Compliance - How is compliance to IEC 62304 verified? RickQualityGuy IEC 62304 - Medical Device Software Life Cycle Processes 18 16th May 2012 09:24 AM



The time now is 09:40 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272