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 They came into our company that had a crappy quality system and only wrote us up for someone's business card being out of date...come on!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 They came into our company that had a crappy quality system and only wrote us up for someone's business card being out of date...come on!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