Having been through this process, I am prepared rather to offer some advice on the process, rather than regarding specific NBs. You will want to make your own list of characteristics important to you, and their priorities in importance - particularly identifying which are "musts" and which are "wants". Some items that may be important include:
Global reach - to include wherever you may want to sell your products.
Evidence of awareness of and preparedness for changes ahead in the IVD area. The new IVD regulation in Europe will require NB involvement with 80% of IVD products instead of the current 20%. This has serious staffing implications for any NB.
Congruence of approach to compliance between your company and the NB.
Administrative efficiency of the NB (something you can only learn about by interviewing current customers)
Location of your representative in Europe
I suggest preparation of a list of questions that you can ask of 4 - 6 of your top candidates. The last of your questions should be to find a few clients that you can call for reference. In my experience, even competitor representatives were happy to share information about their NB.
When you get down to the top two or three, you may invite them to send representative(s), perhaps including a lead auditor, to discuss the possibility of a relationship and how they would operate.
This is a task that ranks up with Hiring Staff in importance. Good luck.
Bill
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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 05-30-2014 08:46
From: Paul MacDonald
Subject: Notified Bodies
We are shopping around for a new Notified Body that specializes in IVD medical device products for ISO 13485 Certifications and EC Certs for self testing devices. Does anyone have a recommendation?
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Paul MacDonald PhD
Chief Qual & Reg Aff Off
NOVA Biomedical Corp
Waltham MA
United States
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