Notified Body Performance Trending Poll
- Thread starter Ed Panek
- Start date
True but I am trying to gauge a perception I have to actual feedback even though most QARA folks are salty regardless
I'm certainly salty - I wouldn't mind the delays too much except my NB is not very forgiving in regard to timelines for responses to MDSAP observations
I don't want to de-rail the thread and I find this poll to be extremely interesting. I also hope that there is space and willingness to discuss the reasons behind the NB "perceived turmoil". It seems to me that the reduction in the numbers of NB's in the marketplace is the result of a concerted crack down due to reported shoddy performance by some NB's.
Under the heightened oversight and potential for multi-million euros lawsuits, NB's (that decided to remain in the business) have been forced to enhance their work practices, hire highly specialized (expensive) professionals and cope with significantly increased workloads.
Differently from the accredited management system certification sector, designated NB's work in highly regulated capacity and the member countries authorities HAD to take action in order to maintain public safety. So, the current squeeze in NB service providers is ALSO a byproduct of the attempt by many organizations of seeking cheap/fast/easy NB's. Personally, I am glad that the commoditization phenomenon that has severely downgraded market confidence inISO management system certificates has been reverted in the NB sector, because, in the end, Society and Business gain NOTHING from worthless certificates and I wish a similar crack down would take place in system certification.
Under the heightened oversight and potential for multi-million euros lawsuits, NB's (that decided to remain in the business) have been forced to enhance their work practices, hire highly specialized (expensive) professionals and cope with significantly increased workloads.
Differently from the accredited management system certification sector, designated NB's work in highly regulated capacity and the member countries authorities HAD to take action in order to maintain public safety. So, the current squeeze in NB service providers is ALSO a byproduct of the attempt by many organizations of seeking cheap/fast/easy NB's. Personally, I am glad that the commoditization phenomenon that has severely downgraded market confidence in
Watchcat
Trusted Information Resource
Well, judging from all the "feedback" all over the internet and on back channels, I think you can just report 100% "worse." Unless of course there are some NB moles here in the Cove.
And I'm not sure they are all that thrilled with the way things have gone the last 6-12 months, either. I would like to say that the interesting question is how things compare for the next 6-12 to the last 6-12, although some NBs seem likely to get crunched by the IVDR too, deja vu all over again.I also wonder how many people understand how long it takes these things to happen, realistically. CDRH still has never full implemented the QSR, passed in 1997. FDASIA, 2012, the second largest and most impactful legislation since the 1976 Amendments...heh. And speaking of the 1976 Amendments, they've never finished that work, either. It not only takes years, at some point it all become irrelevant, as the industry changes, the environment changes, new legislation gets band-aided on top of old.
It's like moving into a new house. You start unpacking and putting away but soon life rushes in, and some boxes end up being shoved up into the attic or back of the closet, where they sit until the next time you move. Or your heirs come in to clean out the place,
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Well, I think from my perspective I think NB are resistant to taking our money, which I know is ridiculous but I feel like we are lately saying "Here, we want you to torture us and take our actual money to fill your coffers!" I mentioned in another thread how we are requesting work with NB and they are taking a ridiculous amount of time to respond compared to, say, 3 years ago. This must mean they are more choosy with clients due to (Insert lots of reasons here)
We also see evidence that a company we engaged to be our UK MHRA in-country rep is "learning on the fly." Case in point, we engaged them last June to start the process, went through a few rounds of back and forth over our tech file and just this week we receive "Oh please fill out this XLS with all your UDI-DI info for all your products you want to sell into UK" We can do that no problem but why in the 11th hour is this being asked? Most logical reason to me is the learning curve.
I highly suspect NB are now learning the unknowable details of putting a new law into effect. I suspect there is a lot of firefighting and legal advice being communicated and to help protect themselves the NB are being highly selective in the clients they take on.
We also see evidence that a company we engaged to be our UK MHRA in-country rep is "learning on the fly." Case in point, we engaged them last June to start the process, went through a few rounds of back and forth over our tech file and just this week we receive "Oh please fill out this XLS with all your UDI-DI info for all your products you want to sell into UK" We can do that no problem but why in the 11th hour is this being asked? Most logical reason to me is the learning curve.
I highly suspect NB are now learning the unknowable details of putting a new law into effect. I suspect there is a lot of firefighting and legal advice being communicated and to help protect themselves the NB are being highly selective in the clients they take on.
Watchcat
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Yes, they have been choosy with clients from the start, when they didn't have anything like the bandwidth needed to respond to all requests, even from existing clients...maybe still don't.
I'm not sure some of the big NBs are ever going to stop being choosy. Big companies with lots of devices, adequate resources to comfortably meet standards, and lots of repeat business, are way more attractive than small companies with one or a few devices. They may fill up their dance cards with the multinationals, and that will be about it. They are likely to accept startups that have partnered with existing clients as potential targets for acquisition. I suspect they might also vet startups for their potential as personal investments for NB executive management and board members, but these days my cynicism knows no bounds.
If I had to guess, same as me. UDI is new. It is mentally queued up after all the "first things first" that have been first things for years. It has not been mentally integrated into the long-standing process flow yet.
What is the alternative? Postpone the entire thing for another year...or more, until everyone that needs to be trained has been?
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chris1price
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There are no surprises with the NB performance. If I think back to the introduction of the MDD in the later 1990, I remember approaching three major NBs, 2 were not interested in my business. It probably took 5 years of "learning on the fly" before the requirements settled down and CE Marking became routine business. The MDR is a major overhaul and everyone is starting again from scratch. I am not surprised by anything I hear now.