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  • 1.  Notified Body Transfer Plan - Any Advice?

    Posted 12-Aug-2015 17:41

    Good Afternoon,

     

    I am working on a Notified Body change and am trying to find guidance on putting together a transfer plan. Does anyone have a template or guidance on what is helpful to include? I'm also looking for a labeling plan relating to changing the CE number as we make the move to a new Notified Body.

     

    Thank you all in advance for any help you could provide.

     

    Cheers,

    Haven


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    Haven McCall, DRSc
    Quality Assurance Regulatory Affairs Professional
    United States
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  • 2.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 12-Aug-2015 18:11
    Haven,

    There is a good guidance for your questions here.

    Just from my curiosity, is it a voluntary change or an enforced change (e.g., NB ceases its activities)? 

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



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  • 3.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 06:30

    Dear Haven,

    check

    http://www.nbog.eu/resources/NBOG_BPG_2006_1.pdf

    look on the Nbog website, there is other interesting staff.

    In case you need more detailed information or help for firefighting- http://www.medidee.com/

    Best


    ------------------------------
    Michael Maier
    Partner
    Medidee Services SA
    Chables
    Switzerland

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    Original Message


  • 4.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 10:47

    Hi Michael,

    Thank you for the link. It is very helpful and I found some other documents that I can use for guidance in this transition.

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    Haven McCall
    Quality Assurance Regulatory Affairs Professional
    United States
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    Original Message


  • 5.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 08:00

    Hello...just FYI, When they acquired and transferred marks of  companies to 3M's Notified Body, 3M negotiated a transition period so that inventory did not have to be scrapped or reworked.  But the Notified Body did go down and audit the operations of those companies.

    Be sure your plan and discussions include this aspect.

    Best regards,

    Ginger Cantor, RAC
    Centaur Consulting LLC
    715-307-1850
    centaurconsultingllc@gmail.com




    Original Message


  • 6.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 10:46

    Hi Ginger,

    Excellent point. Thanks for adding that detail. 

    -Haven

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    Haven McCall
    Quality Assurance Regulatory Affairs Professional
    United States
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    Original Message


  • 7.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 08:59

    Haven,

    The document that both David and Michael provided links to is quite good and will have answers to most of your questions.  I would add only a few thoughts.

    The Notified Body is a service provider and thus you need to be sure in choosing your new NB that you follow company procedures for qualifying service suppliers. 

    You will need to manage this with the same level of detail as for the development of a new product.  You may wish to enlist project management resources from other departments. 

    The most expensive piece of this effort is likely to be the labeling that shows the NB number.  Your company will appreciate any successes you have in minimizing this cost.

    If you have not yet reviewed the coming European regulations, you should do so, just to be sure that whatever you do now in connection with the NB change does not have to be redone when those regulations come into force in a few years.

    Work as closely as possible with both NBs.  The current drafts of the new regulations I believe require a three way contract for this situation.  This is not currently a requirement (as far as I know) but it does indicate the importance of working closely with both.

    Best of luck with the ordeal.  (I have done it and survived, so I am sure you will also.)

    Bill

    ------------------------------
    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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    Original Message


  • 8.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 10:45

    Thank you for your guidance. Much appreciated!

    -Haven

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    Haven McCall
    Quality Assurance Regulatory Affairs Professional
    United States
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    Original Message


  • 9.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 10:50

    Haven,

    Recently helped a client with a similar project...  In addition to all the recommendations previously posted, one area that seemed to garner more focus from the (new) NB than required by the former was in the area of unannounced vendor audits — questions regarding the particulars of contracts with suppliers, provisions for receiving NB unannounced audits, etc.  NBs do not want to arrive for an unannounced audit and then learn the supplier only processes your product/subassembly/component the first week of each month.  You may want to involve your Supplier Quality and Purchasing Teams early in the process.

    If your project affects many products/UPNs, you may want to carefully plan how you will "batch" the transitions – and plan/negotiate with both NBs up-front, as it is likely both NBs may impose additional fees for Certificate revisions.  This will need to be coordinated with your Dossier/Tech File reviews.

    Finally, where you may happen to have any open observations from prior audit findings, strongly recommend resolving and closing them with your current NB as promptly as possible.

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    Dennis Henkelman
    Principal
    Dennis W. Henkelman & Associates Inc.
    San Francisco CA
    United States
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    Original Message


  • 10.  RE: Notified Body Transfer Plan - Any Advice?

    Posted 13-Aug-2015 14:29

    I am also curious as to why you are switching notified bodies. 

    If you have products that are CE Marked based on an NB's review of the design dossiers, then when those certificates come up for renewal, the NB that did the previous review is likely to review only the documentation that has been added to the dossier (e.g., design changes) since they reviewed it last time.  If you switch NBs, when it is time to renew the CE Certification, the new NB may feel the need to review the entire dossier from scratch.  If this scenario applies to you, it is something you probably want to discuss with your new NB before they become your new NB, rather than after.


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    Julie Omohundro RAC
    Durham NC
    United States
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