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23rd May 2005, 11:47 PM
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I need a reference for selecting a notified body. Can anyone make a recommendation?
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
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24th May 2005, 01:01 AM
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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....
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24th May 2005, 08:00 AM
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Sidney, if you recommend my employer I'll recommend yours. 
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24th May 2005, 09:16 AM
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Mdd
Sidney,
We are a medical device company. So we are under the Medical Device Directive 93/42.
Thanks,
Larry
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24th May 2005, 10:02 AM
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Quote:
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Originally Posted by Larry Pool
Sidney,
We are a medical device company. So we are under the Medical Device Directive 93/42.
Thanks,
Larry
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Larry 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,
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Al
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9th August 2005, 06:06 PM
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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.
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9th August 2005, 09:28 PM
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Good for ya Rosie my dear!! 
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None of us is as smart as all of us...Ken Blanchard
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10th August 2005, 08:43 AM
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QA-LA
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I hear BSI and DNV are good, as well as KEMA. I also recommend NSF-ISR 1-888-NSF-9000.
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