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  Post Number #1  
Old 24th May 2018, 04:13 PM
DEVigil

 
 
Total Posts: 32
Please Help! NB/CB Unresponsive

Hello, fellow Covers!

I am at my wits' end. We are a small startup, and have a contract with a certain NB/CB for our ISO 13485 cert and CE marking of software medical devices. I have been trying since January to get surveillance audit dates for this year. Our audits are supposed to be in May, and as you can tell by the date of this post there isn't a whole lot of May left... and I still have no indication when we might be scheduled, despite numerous requests. They claim to have a (presumably internal) rule that audits can be +/- two months, but aside from that they have made no move to actually schedule us.

We also recently added a new product, for which we submitted the proper notification to the NB. This product, for which our 510(k) was successfully processed in under 30 days, needs its technical file reviewed before we can CE mark it and sell in the EU (which is where the customer base is). No word on when that will be taken up either - and Executive Management is steaming, because we have distributors lining up who won't be able to sell it until this is done, and we can't even give an estimate of when that might be because we can pry nothing out of the NB.

Our CEO is threatening to chew his way up the food chain at the CB/NB, and I am seriously contemplating lodging a formal complaint with the relevant Competent Authority. I'm worried there will be retributive backlash during subsequent audits, but at this point I'll take that if it means we actually get them.

I'd appreciate any and all advice on how best to deal with this situation. Also, I know the NBs are all slammed, but at this point advice on how to change NBs (i.e., timing) would also be welcome.

Thanks for hearing me out!
Debra

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  Post Number #2  
Old 24th May 2018, 04:21 PM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,690
Re: NB/CB Unresponsive

I ran into that with one of the big registrars in the US and we fired them and moved over to another registrar.

but you have the added complexity of technical files involved...

I would take a 2 prong approach - let your CEO chew his way up the NB's chain of command while at the same time approaching other NBs and getting quotes and conditions for transferring.

It sounds to me, however, your best bet may be moving on even if the current NB does respond eventually... the trust is gone and that's pretty critical between a company and it's NB.
Thank You to ScottK for your informative Post and/or Attachment!
  Post Number #3  
Old 24th May 2018, 08:47 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,315
Re: NB/CB Unresponsive

Quote:
In Reply to Parent Post by DEVigil View Post

Our CEO is threatening to chew his way up the food chain at the CB/NB
As the cliche' goes, insanity is keep doing the same thing and expecting different results. NB/CB scheduling functions are under a lot of stress at the moment and your organization needs to escalate the issue ASAP. If you keep trying to get the issue resolved with the scheduler and/or auditor you will be keep getting the run around.

Most people want to have as little contact as possible with their CB's/NB's and know next to nothing about the CB/NB organizational structure. That is one of the prices they pay. The NB/CB are so opaque that they don't know whom to call/contact when the regular communication channels are not working.

There are several things you can do in order to put pressure on the CB to resolve the issue. One, for example, is a threat warning that you might disclose who they are in a place like The Cove...

Good luck.
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #4  
Old 24th May 2018, 09:43 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,940
Let Me Help You Re: NB/CB Unresponsive

Quote:
In Reply to Parent Post by DEVigil View Post

I'm worried there will be retributive backlash during subsequent audits, but at this point I'll take that if it means we actually get them.
If you detect that (and, typically the auditor won't know what happened before) I'd show them the door, then lodge a complaint with the powers that be. "Retribution" from a supplier of such a service is totally unacceptable.
  Post Number #5  
Old 9th June 2018, 09:19 AM
Access2hc's Avatar
Access2hc

 
 
Total Posts: 40
Re: NB/CB Unresponsive

write to the CB/NB executive management, to lodge a formal written complaint - remember that they are your suppliers!

in parallel find another CB/NB to help you. If you have issues with the branding of the CB/NB, you can always switch to another NB later, administrative procedures.

if you're still stuck just PM

Cheers,
Ee Bin
Access2hc
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