NB/CB Unresponsive

DEVigil

Involved In Discussions
#1
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
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
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.
 

Sidney Vianna

Post Responsibly
Staff member
Super Moderator
#3
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...:mg:

Good luck.
 

AndyN

A problem shared...
Staff member
Super Moderator
#4
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.
 

Access2hc

Involved In Discussions
#5
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
 

Donetta

Registered
#6
My company has had similar problems locking down audit dates. Our NB scheduled our technical file audit for January and then postponed (it seems indefinitely). Our recertification for ISO 13485 audit is due October of this year as well... They recently - 2 months ago - sent us a letter stating they 'might not' be able to schedule that recertification audit before the certificate expires and we should perhaps look elsewhere to get the audit done.

I started looking for quotes from other notified bodies a YEAR ago (we haven't been happy with our current NB for quite some time) and finally received quotes in March from 2/3 companies I request them from. One of them wouldn't commit to auditing this year (Pointing the finger at you CMDCS/MDSAP!) and the other wants $10k nearly upfront in order to "transfer."

As a small startup (I feel you), $10k is a significant amount/hurdle to jump to a new NB.

It's looking more and more like we're going to have a lapse in our certificates. Our CE is good until 2020, but is subject to satisfactory surveillance audits and since we haven't been able to schedule one for this year, I think we're in trouble.
 

Mark Meer

Trusted Information Resource
Trusted
#7
write to the CB/NB executive management, to lodge a formal written complaint - remember that they are your suppliers!
Were it only so easy. As Sidney points out, the organizational structure is often inaccessible, so finding any contact points to "executive management" is challenging. Also, there's a good possibility that you'd just get the same level of unresponsiveness.

...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.
Again, if only it were so easy. Switching NBs is no trivial matter, and for small companies can be a huge risk both financially and operative.

In my experience, part of the problem is that when you are shopping around, reps are all too eager to accommodate. This can lead to a false sense of service, only to find out that once a contract is signed and money exchanged, the level of service takes a dive...

I wish I had some further advice, but it seems that what Donetta and Debra are doing is as much as possible. Certainly (a) attempt to lodge a complaint to whatever authority possible; and (b) shop around for alternatives. ..but the unfortunate reality is that neither of these are a guarantee of a better situation...
 

psp1234

Involved In Discussions
#8
I had the same issue with scheduling an audit this year. I got an audit date 3 weeks before the audit :bonk::bonk::bonk:

I am wondering why we don't have a section in the forum to rate registrars and NBs. It might be helpful.
I am sure they will appreciate the feedback :sarcasm: as they are preaching for "customer satisfaction" in their audits.

sue
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
I had the same issue with scheduling an audit this year. I got an audit date 3 weeks before the audit :bonk::bonk::bonk:

I am wondering why we don't have a section in the forum to rate registrars and NBs. It might be helpful.
I am sure they will appreciate the feedback :sarcasm: as they are preaching for "customer satisfaction" in their audits.

sue
There are a lot of registrar auditors and managers on this site as participants (and some moderators)….

Be sure... they see this stuff and know our pain.
 

DEVigil

Involved In Discussions
#10
Here is the follow up to my original post...

We finally got audit dates for the end of June (less than a month's notice, but we were happy to get them at all). The auditor was the same as we had last year, and we have *no* complaints about that person, or the audit itself, at all.

We didn't get a date for the TF audit until the auditor was on site, despite repeated requests in the interim. The on-site auditor wound up working it into their already very-full schedule at the end of this month. Not what Executive Management wanted, but it was the best we were going to get. And only after prodding did I get the actual proposal for it - today.

In response to my request for the appropriate complaint contact information, I was directed to a 2017 "Customer Satisfaction Survey" on Survey Monkey. This appears to be their only mechanism for registering a complaint, and the survey is directed specifically at satisfaction with on-site audit performance. Other than those questions, there is a space to indicate who your "Customer Care Specialist" is (which is not the job title of anyone with whom I have dealt), and all of two multiple choice questions - one about their communication, one about the acceptability of the audit date. My choices for those are "Very Satisfied," "Satisfied," "Not Satisfied," and "Not Applicable." Finally, there is a single text box at the end in which to express "any additional positive comments or concerns."

I know I'm not exactly objective, but that seems like a joke. Surely they are required to have a complaint handling process...
 
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