I need a reference for selecting a notified body. Can anyone make a recommendation for a NB who is responsive to a small compny's needs? Like providing reasonable lead-times for CE Mark applications and change notice reviews, competive rates and audits to spirit of the standard's requirements rather than the auditor preference.


thanx:

Larry

Larry, I will refrain from recommending a NB since I work for one and I am biased, but, in order for you to get some suggestions it would be benefitial for you to identify which Directive(s) you need a NB for. MDD, PED, ATEX, etc....

Sidney, if you recommend my employer I'll recommend yours. :lol:

Sidney,

We are a medical device company. So we are under the Medical Device Directive 93/42.

Thanks,

Larry

Sidney,

We are a medical device company. So we are under the Medical Device Directive 93/42.

Thanks,

LarryLarry I will recommend a Notified Body that has some experience with the same or similar Medical Devices. Perhaps this thread would be better placed in the 13485 Medical Device Forum. If it doesn't get many responsives in the next day or so, I can move it,

When I was working in medical devices I interviewed BSI, TUV and Lloyds for both my ISO registrar and my notified body. They were all good. We hired BSI and found them to be excellent to work with.

Good for ya Rosie my dear!! :bighug:

I hear BSI and DNV are good, as well as KEMA. I also recommend NSF-ISR 1-888-NSF-9000.

I hear BSI and DNV are good, as well as KEMA. I also recommend NSF-ISR 1-888-NSF-9000. Are they a NB for the MDD?

We do have references we can provide you with .....for KEMA of course.:bigwave:

We do have references we can provide you with .....for KEMA of course.:bigwave:Are you affiliated with KEMA?

yes I am.

BSI is awful for medical devices! They came into our company that had a crappy quality system and only wrote us up for someone's business card being out of date...come on! We paid thousands of dollars for that??

Depending on the type of medical device, try looking into TUV, DNV or Amtac, to name a few. In the end, I don't think it matters who the certifying body is, companies just want to know that you are certified.

BSI is awful for medical devices! They came into our company that had a crappy quality system and only wrote us up for someone's business card being out of date...come on! We paid thousands of dollars for that??

You raise quite a point here.... Have you or someone else in your organization contacted BSI and expressed your dissatisfaction with the quality of their services?

What did you expected to happen for "thousands of dollars?"

Realizing that the organization had a "crappy quality system", why wasn't the system brought "up to standard?"

Stijloor.

Business card??

That's just wierd, and certainly would/should have been challenged when I was at BSI. Good guys, highly professional, (but obviously BSI shares the same issues any organization does).



There are quite a few NB representatives on the Cove, including myself (SGS). I would just suggest doing a little bit of homework, including reading the various contributions on the Cove, and go with an organization that gives you the best vibes for the best cost.

If you have any specific questions, go for it! :)

We are a medical device (class II) manufacture, sales in US, Canada & International. We use SGS, they also cover the Canadian registration.

Phil

Hi everyone, sorry to jump on the topic but this brings up a few questions for me:

Does anyone know how NBs charge for auditor travel (pass through or flat fee), annual file maintenance fees, application fees, etc.

Which NB do you think has the most auditors for medical and in vitro devices?

I'm considering the TUVs (Sud and Rheinland) and BSI, but as with any "professional services", I'm quite puzzled by the opacity of prices

When I was at BSI (in the UK) we charged a flat fee, that was built into the original quote. That would cover travel time, accommodation, flight costs, the works.
It was fast but crude. And whilst subject to inaccuracy, it was basically fair overall, and of course highly transparent.


At SGS we exclude expenses from the original quote, however basic travel time (approximated) is built into the original quote. The final costs are exact, but you can only guesstimate expenses up front. From my own experience I can say that flight costs are all over the place in the US, so there is a deal of variation there. On the plus side, you may end up having a flight ticket cost split if I visit one or more clients in the same week as you.


I can't speak for the various TUVs, but I wouldn't have described either BSI's or SGS's quotation processes as opaque.

What I would suggest is...talk to the NB. They want your business, so if you ask (sensible, fair!) questions they will be pleased to answer.

Are they a NB for the MDD?

Not as far as I could tell from their website. To be 100% sure would need to the NB listing.

Hi everyone, sorry to jump on the topic but this brings up a few questions for me:

Does anyone know how NBs charge for auditor travel (pass through or flat fee), annual file maintenance fees, application fees, etc.

Which NB do you think has the most auditors for medical and in vitro devices?

I'm considering the TUVs (Sud and Rheinland) and BSI, but as with any "professional services", I'm quite puzzled by the opacity of prices



I don't handle too much on the money side of things, but just to answer in general terms how we calculate overall costs:

1. What do you want? ISO13485, MDD, CMDCAS, Class III device dossier examinations?

2. What is your organisation? Activity, locations, staffsize, outsourcing, types of product etc etc

3. What else is unusual about your application?


It is often very complicated stuff. I know our people spend a long time trying to get it (the "application") right. So from an SGS perspective the application fee is for the initial audit, all the preparation involved, plus quotes for the first surveillance periods, the cost of post-audit review, and certification issue.


In terms of "file maintenance fees" etc. I would just ask, that's probably "NB-local" terminology.

Thanks Roland,

I just always dread calling sales people, but thanks for the surface info :)

Hi everyone, sorry to jump on the topic but this brings up a few questions for me:

Does anyone know how NBs charge for auditor travel (pass through or flat fee), annual file maintenance fees, application fees, etc.

Which NB do you think has the most auditors for medical and in vitro devices?

I'm considering the TUVs (Sud and Rheinland) and BSI, but as with any "professional services", I'm quite puzzled by the opacity of prices

Matt,

This isn't a simple question because they all vary (as do service providers in other fields). I understand it may be confusing, but that's why they pay sales people! And you have to deal with the sales people ultimately - it's their job. And they need specific information from you to get it right, because it takes them a while to work out all the input factors, to provide an accurate quote. (Otherwise it's a bit like asking: how much does it cost to get a building inspected? without you saying what kind of building, where it is, how big it is, what kind of inspection you need, etc etc).

Insist upon, and make sure, you get a 'total cost of certification' quote out of each of them, so that you really can compare 'apples with apples' as it were.

You see, one company may not include a charge that another one does. For example here, most companies charge no travel fees at all for audits within capital cities. Some charge a cost for actually issuing the certificate, some don't. That's why you need a 'total quote'.

And if you don't understand it, keep asking until you do - and get it in writing of course.

Word of warning: if you happen across one that's much cheaper than most, don't go for the rockbottom cheapest. There's usually a damned good reason why they're so cheap, and it's rarely a good one. :nope:

Do your due diligence of course, eg: check out other client's experiences with them. And ask to see CVs for the auditor/s they'd assign (to get an idea of what kind of auditor & whether you think would be suitable)

And don't, by the way, be put off by the earlier poster who put down a single CB - no one should do that for what may well have been a problem with just a single auditor, without first going through the normal channels: ie, taking it up with the CB and giving them an opportunity to fix the problem.