The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page

View Full Version : I need a reference for selecting a notified body. Can anyone make a recommendation?


Larry Pool
23rd May 2005, 11:47 PM
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

Sidney Vianna
24th May 2005, 01:01 AM
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....

Randy
24th May 2005, 08:00 AM
Sidney, if you recommend my employer I'll recommend yours. :lol:

Larry Pool
24th May 2005, 09:16 AM
Sidney,

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

Thanks,

Larry

Al Rosen
24th May 2005, 10:02 AM
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,

RosieA
9th August 2005, 06:06 PM
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.

Randy
9th August 2005, 09:28 PM
Good for ya Rosie my dear!! :bighug:

Aaron Lupo
10th August 2005, 08:43 AM
I hear BSI and DNV are good, as well as KEMA. I also recommend NSF-ISR 1-888-NSF-9000.

Al Rosen
10th August 2005, 09:12 AM
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?

Cem Onus
6th June 2008, 04:07 PM
We do have references we can provide you with .....for KEMA of course.:bigwave:

Al Rosen
6th June 2008, 04:31 PM
We do have references we can provide you with .....for KEMA of course.:bigwave:Are you affiliated with KEMA?

Cem Onus
6th June 2008, 04:37 PM
yes I am.

4Compliance
29th October 2008, 01:35 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.

Stijloor
29th October 2008, 02:21 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??

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.

Roland Cooke
29th October 2008, 02:23 AM
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! :)

Phil Fields
29th October 2008, 09:39 AM
We are a medical device (class II) manufacture, sales in US, Canada & International. We use SGS, they also cover the Canadian registration.

Phil