Regulatory Open Forum

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  • 1.  Notified Body Feedback

    Posted 14-Dec-2016 12:00

    Hi RAPS Colleagues,

    I have a client that will need to select a notified body next year.  I have experience with several different notified bodies, but I would like to collect the input of the group regarding notified body experiences.

    Can you share with me who your notified body is, how long you've been with them, what you like and don't like about your NB?  How easy are they to work with?  How transparent are they?  How quickly do they review your design dossiers?  Do you have to submit all changes to them or only significant ones? 

    Thank you in advance for your feedback!

    ------------------------------
    Julie Broderick RAC
    Principal/Consultant
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States
    ------------------------------


  • 2.  RE: Notified Body Feedback

    Posted 15-Dec-2016 10:47

    Hi! 

    I have worked with BSI, TUV SUD, and DEKRA. In my opinion, they are all the same. Timelines are longer and longer and they all have to adhere to the same rules and regulations thus there are no differences in which changes you have to submit or not. 

    Good luck!

    ------------------------------
    Jan Flegeau
    Directory of Regulatory Affairs

    Original Message


  • 3.  RE: Notified Body Feedback

    Posted 16-Dec-2016 10:16

    Jan,

    Yes, together we worked with all of the notified bodies at one point. Don't forget to mention that due to staff issues and inefficiencies in managing the office bureaucracy, at one point the notified body put Canadian market access in

    Don't forget to mention that due to staff issues and inefficiencies in managing the office bureaucracy, at one point the notified body put Canadian market access in jeopardy because of a lack of QMS certificates. (Not the evaluation, mind you, but the issuance of the paper certifications). <g class="gr_ gr_827 gr-alert gr_gramm gr_run_anim Style multiReplace" id="827" data-gr-id="827">This  paperwork</g> delay resulted in an organization's wholesale move to a different notified body.

    Because of the sweeping changes in global medical device regulations and compliance standards along with greater responsibilities and oversight of notified bodies, this staffing situation with the remaining notified bodies will exacerbate. Thye are recruiting furiously and efforting to fill this staffing gap, but will the notified bodies have the trained staff in place to handle these new requirements and workload?

    Choosing the right notified body is critical to a global business, and an important consideration is how each <g class="gr_ gr_731 gr-alert gr_gramm gr_run_anim Grammar multiReplace" id="731" data-gr-id="731">are</g> managing this transition to these new realities and responsibilities.

    ------------------------------
    Michael Chellson
    RAC

    Original Message


  • 4.  RE: Notified Body Feedback

    Posted 15-Dec-2016 12:56

    I migrated us from SGS to BSI last year. In our experience, especially in the Med device space, the name alone as the NB provides excellent marketing and business partnerships.

    Pros' - Name, recognition, depth of knowledge, training, standards, expertise, consulting all are top tier.

    Con's - a bit more pricey in my opinion than others, however, the costs are fixed which makes budgeting easier. 

    Greg

    ------------------------------
    Gregory Kleinert MS, CQA, PE
    Biocoat, Inc.
    United States

    Original Message


  • 5.  RE: Notified Body Feedback

    Posted 15-Dec-2016 22:11

    I have worked with TUV SUV and BSI before in my opinion they are both the same. 

    ------------------------------
    Edenia

    Original Message


  • 6.  RE: Notified Body Feedback

    Posted 16-Dec-2016 08:37

    Hi Julie,

    We've been a happy BSI client for >10 years. I think they are more expensive, partly because they do a biannual sterilization/microbiology audit. Other companies cover sterilization/microbiology in their standard audit cycle.

    BSI has been predictable and able to support us with knowledgeable reviewers. The requirements for notifications on product changes, etc. are clearly documented in their conditions of contract. I can't compare how they are against others on that front. We have had 1 unannounced audit and I thought the process they used made a lot of sense.

    The only feedback I've heard on other NBs was a comment from a distributor that Intertek (in the UK) was very slow in a recent review and that the Competent Authority was preventing them from taking on additional work until they added resources. This info is second hand so I can't vouch for absolute accuracy.

    Good luck and Happy Holidays!

    Ian

    ------------------------------
    Ian Christianson
    Marlborough MA
    United States

    Original Message


  • 7.  RE: Notified Body Feedback

    Posted 16-Dec-2016 10:22

    I have had/heard of mixed experiences with the large NBs.  I attribute this in part to the fact that, with any organization, the specific people assigned to assist you can be as or more important than the organization itself, and, the larger the organization, the more likely this is to be true.  Moreover, how good an experience you have with an NB also depends on how knowledgeable you are, how well you hold up your end of the deal, what your expectations are.  The startup who expected to get their 510(k) cleared in 90 days often doesn’t think much of FDA, but I don't see that as FDA's problem.

    All of this is especially true if you need them to review a Class III design dossier. In that case, I would look for an NB that has clinical expertise on board.

    I am assuming you are aware of the numerous reasons that this is not a happy time to be looking for an NB, especially for a Class III dossier review.  Your client should also be aware that, if they decide to change NBs (or an NB simply decides not to bother to re-certify their device), the new NB will almost certainly require a full review of the dossier, not just the usual re-certification review, and the fact that the first NB was happy with the way you did something doesn’t mean the new NB will agree.

    Finally, because of all the changes going on and about to occur, I would remember that "past behavior is the best predictor of future performance" applies only "within the current range of conditions."  Experience with an NB three years ago may not be at all predicative of experience with that same NB next year.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com

    Original Message


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