Regulatory Open Forum

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  • 1.  Standards Update Notification Service

    Posted 30-May-2013 14:32

    Good afternoon,

    I have been asked to look into services that notify us when a standard we use has been updated.  I know BSI provides this service, however, I am not sure that it makes sense financially.

    I have seen other companies that will provide you with this service once you purchase the standards from them.  It again, financially, does not make sense to re-purchase 150+ standards.

    So basically what I am looking for is a company whom I can provide a list of standards to and them notify us when they have been updated at a reasonable price.

    Any help is appreciated.  

    Elena  
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    Elena Cavaliere
    Regulatory Affairs Specialist
    Barrie ON
    Canada
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  • 2.  RE:Standards Update Notification Service

    Posted 31-May-2013 06:02
    I use a company call Techstreet at  www.techstreet.com/

    I doesn't cost to set up an account. You can then track standards and get an e-mail when one of the tracked standrds change.


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    Dan O'Leary
    Swanzey NH
    United States
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  • 3.  RE:Standards Update Notification Service

    Posted 03-Jun-2013 15:01
    I agree with Dan... Techstreet is free and you don't have to purchase standards from them to use their notification service.  It works great for my company especially since we get member discounts from other standardization organizations, such as ASTM and AAMI.

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    Tatyana Bogdan
    Regulatory Affairs Manager
    Cardinal Health
    Waukegan IL
    United States
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  • 4.  RE:Standards Update Notification Service

    Posted 03-Jun-2013 15:10
    Thanks Tatyana

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    Trilo Das ' Regulatory Affairs Specialist

    On-X Life Technologies, Inc.
    Austin, Texas 78752





  • 5.  RE:Standards Update Notification Service

    Posted 04-Jun-2013 08:58

    It is worth the effort to periodically monitor the Standards websites (ISO, IEC, CEN, CENELEC, and AAMI) to see where in development those standards are.   That enables the Subject Matter Experts to expect and prepare for the changes rather than react.

    We also use IHS Watchlists to notify us when a standard is published, but that trigger can be too late, especially if the EU  expects a short transition period for standard implementation.  IHS does give us early access to drafts of standards.  Invaluable.
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    Renee Maria Bernard
    Staff Specialist Quality and Compliance
    Ethicon Endo-Surgery
    Cincinnati OH
    United States
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  • 6.  RE:Standards Update Notification Service

    Posted 31-May-2013 09:23
    We use http://global.ihs.com/.  $150 for ~50 standards.  They have various packages, depending on the # of standards, etc.

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    Tim White
    Leadership, QA
    Abrasive Technology, Inc.
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  • 7.  RE:Standards Update Notification Service

    Posted 31-May-2013 13:59
    Thank you all for your help!!

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    Elena Cavaliere
    Regulatory Affairs Student
    Barrie ON
    Canada
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  • 8.  RE:Standards Update Notification Service

    Posted 03-Jun-2013 09:15
    I check for new standards and regulations that apply to our business on a monthly basis, and we use IHS Global for the update service for standards already purchased. You do not have to repurchase the standards in order to give them the list of standards you have that need to be monitored. It does cost, but not more than what the time you'll spend looking for updates yourself will cost.

    I also use AAMI standards on CD subscription services. Once you buy the initial annual subscription, it's only about $400 per year to update a very large number of standards regarding medical devices and sterilization, and those that come out after the CD is published are available to download from their site. It saves a bunch of money in the long run, and we've found this to be the most cost effective approach. Many AAMI standards are also IEC, ANSI, and ISO standards.

    There are other service providers as well, but I do recommend that you get a standards provider that is not related to a standards organization, such as ISO or BSI. You will get only ISO and BSI standards updates, and you probably use standards from many organizations.

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    Paula Bojsen
    Global Regulatory Compliance Manager
    Ranir Global
    Grand Rapids, MI
    United States
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  • 9.  RE:Standards Update Notification Service

    Posted 31-May-2013 12:23
    Hi Elena,

    I think that both TechStreet and ISO offer a free service to let you know when standards have changed. The Emergo group has a free newsletter that gives some context, as well.

    When you are ready to purchase a new standard, be sure to check if it is available from Estonia
    http://www.evs.ee/shop

    They offer English language standards at a fraction of the cost.

    Cheers
    Karen

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    Karen Long
    Richmond BC
    Canada
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